Tissue management apparatus for vascular access

ABSTRACT

Tissue management methods can include inserting a clamping device into a vessel and clamping a vessel wall via the clamping device. Tissue can be dilated about the clamping device and an anastomotic device provided to the vessel.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/781,575, filed on Feb. 28, 2013, titled TISSUE MANAGEMENT APPARATUSFOR VASCULAR ACCESS, which is a continuation of U.S. patent applicationSer. No. 12/480,678, now issued as U.S. Pat. No. 8,409,228, filed onJun. 8, 2009, titled TISSUE MANAGEMENT METHODS, APPARATUS, AND SYSTEMS,which claims the benefit under 35 U.S.C. §119(e) of U.S. ProvisionalPatent Application No. 61/059,590, filed on Jun. 6, 2008, titledVASCULAR ACCESS METHODS, APPARATUS AND SYSTEMS, the entirety of each ofwhich is hereby incorporated by reference herein.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

The invention was made with support from the U.S. Government under GrantNo. SBIR R43 CA 139608 and Grant No. SBIR R44 CA 139608, which wereawarded by the National Institutes of Health. The U.S. Government hascertain rights in the invention.

TECHNICAL FIELD

The present disclosure relates to methods, apparatus, and systems formanaging tissue.

SUMMARY

Disclosed herein are embodiments of methods, apparatus, and systems formanaging tissue, such as, for example, for preparing a vessel foranastomosis and/or for creating an anastomosis with a vessel.

BRIEF DESCRIPTION OF THE DRAWINGS

The written disclosure herein describes illustrative embodiments thatare non-limiting and non-exhaustive. Reference is made to certain ofsuch illustrative embodiments that are depicted in the figures, inwhich:

FIG. 1 is a cross-sectional view of an embodiment of a clamp assemblyand an embodiment of a clamp actuation device coupled therewith;

FIG. 2 is an enlarged cross-sectional view of an anvil region of theclamp assembly of FIG. 1 in a closed configuration;

FIG. 3 is an enlarged cross-sectional view of a portion of the actuationdevice of FIG. 1;

FIG. 4 is a perspective view of a portion of the clamp assembly of FIG.1 being inserted into a blood vessel that is shown in cross-section;

FIG. 5 is a perspective view of a portion of the clamp assembly of FIG.1 shown in an open configuration with an embodiment of a clamp footseparated from an embodiment of an anvil such that a wall of the bloodvessel is between the clamp foot and the anvil;

FIG. 6 is a cross-sectional view of a portion of the clamp assemblyshown in FIG. 5;

FIG. 7 is a perspective view of a portion of the clamp assembly of FIG.1 shown in a closed configuration with the wall of the blood vesselclamped between the clamp foot and the anvil;

FIG. 8 is a cross-sectional view of a portion of the clamp assembly ofFIG. 7;

FIG. 9 is a cross-sectional view of an embodiment of a tract dilatorassembly in a non-expanded or constricted state;

FIG. 10 is a cross-sectional view of a distal region of the tractdilator of FIG. 9;

FIG. 11 is a cross-sectional view of the distal region of the tractdilator assembly of FIG. 9 shown in an expanded state;

FIG. 12 is a cross-sectional view of an embodiment of an anastomosisactuation device;

FIG. 13 is a perspective view of an embodiment of a retention adapter;

FIG. 14 is a perspective view of an embodiment of an anastomosis clip;

FIG. 15 is a cross-sectional view of an embodiment of an anastomosisconduit;

FIG. 16 is a cross-sectional view of the distal end of the anastomosisactuation device of FIG. 12 in an initial placement position;

FIG. 17 is a cross-sectional view of the distal end of the anastomosisactuation device of FIG. 12 in a position following the cutting of aportion of the vessel wall;

FIG. 18 is a cross-sectional view of the distal end of the anastomosisactuation device of FIG. 12 in a position in which a portion of thevessel wall is captured;

FIG. 19 is a cross-sectional view of the distal end of the anastomosisactuator assembly of FIG. 12 in a position configured to eject aconduit;

FIG. 20 is a cross-sectional view of a conduit anastomosed to a side ofa blood vessel;

FIG. 21 is a perspective, partial cutaway view of an embodiment of aconduit anastomosed to a blood vessel and an embodiment of a hub and anembodiment of an obturator coupled with the conduit;

FIG. 22A is a perspective view of another embodiment of a tract dilatorthat includes a ratchet mechanism;

FIG. 22B is a perspective view of the tract dilator of FIG. 22A inanother operational state;

FIG. 23A illustrates an elevation view of another embodiment of a tractdilator that includes ribbons and a separable sheath;

FIG. 23B illustrates a cross-sectional view of the tract dilator of FIG.23A

FIG. 23C illustrates an elevation view of the tract dilator of FIG. 23Abeing expanded by the insertion of a plunger therein;

FIG. 23D is a perspective view of a portion of a ribbon of an embodimentof the tract dilator of FIG. 23A that includes barbs to resist backoutof the tract dilator;

FIG. 23E is a perspective view of a set of ribbons and linkages that iscompatible with the tract dilator of FIG. 23A shown in a non-expanded orconstricted state;

FIG. 23F is a perspective view of the ribbons and linkages of FIG. 23Ein an expanded state;

FIG. 23G is a cross-sectional view of another embodiment of a tractdilator such as the tract dilator of FIG. 23A that includes a plungertip having grooves that are configured to receive at least a portion ofribbons therein;

FIG. 23H is a cross-sectional view of another embodiment of a tractdilator that includes a balloon;

FIG. 24A illustrates an elevation view and a cross-sectional view ofanother embodiment of a tract dilator that includes a sleeve retained ina non-expanded or folded state by a separable sheath;

FIG. 24B is a cross-sectional view of the same;

FIG. 24C is an elevation view of the tract dilator of FIG. 24A showingthe separable sheath being removed from the sleeve;

FIG. 24D is an elevation view of the tract dilator of FIG. 24A showingthe sleeve being expanded by the insertion of a plunger therein;

FIG. 24E is an elevation view of the tract dilator of FIG. 24A showingthe sleeve in a substantially fully expanded state with the plungerinserted to a distal end thereof;

FIG. 24F is a cross-sectional view of another embodiment of a tractdilator that includes a balloon;

FIG. 25 is a cross-sectional view of another embodiment of a clampassembly;

FIG. 26 is an elevation view of the clamp assembly of FIG. 25;

FIG. 27 is an elevation view of the clamp assembly of FIG. 25 in anotheroperational state;

FIG. 28 is a perspective view of an embodiment of an vascular accessimplantation device;

FIG. 29 is an exploded perspective view of the vascular accessimplantation device of FIG. 28;

FIG. 30 is a perspective view of an embodiment of a primary housing;

FIG. 31 is a cross-sectional view of the primary housing of FIG. 30;

FIG. 32 is a perspective view of an embodiment of a clamp actuationdevice in a closed state;

FIG. 33 is a perspective view of the clamp actuation device of FIG. 32in an open state;

FIG. 34 is a perspective view of the clamp actuation device of FIG. 32in the closed state and displaced as a cutting piston;

FIG. 35 is a perspective view of an embodiment of an anastomosisactuation device;

FIG. 36 is a cross-sectional view of the anastomosis actuation device ofFIG. 35;

FIG. 37 is a cross-sectional view of another embodiment of a tractdilator in a pre-assembled state and a closed configuration;

FIG. 38 is a cross-sectional view of the dilator of FIG. 37 in anassembled state and an open configuration;

FIG. 39 is a cross-sectional view of the dilator of FIG. 37 in anassembled state and in a retraction configuration; and

FIG. 40 is a cross-sectional view of an embodiment of a fully implantedaccess port anastomosed to a blood vessel.

DETAILED DESCRIPTION

Described herein are certain embodiments of methods, apparatus andsystems for managing tissue in connection with attaching an accessdevice to the vasculature of a patient or to some other suitable sitewithin the patient. In some embodiments, an access tube is anastomosedto a vessel and can be used for repeated access thereto, such as forhemodialysis or other procedures. In other embodiments, an access portis anastomosed to a vessel. In various embodiments, the access tube orthe access port can be joined to the vessel via percutaneous proceduresand/or devices.

Although many of the examples provided herein relate to the anastomosisof devices to blood vessels, this method of disclosure is employed forthe sake of convenience and efficiency, but should not be construed aslimiting of the types of procedures with which embodiments may be used.Indeed, embodiments of the methods, systems, and apparatus disclosedherein can be used with vessels other than blood vessels, and may beused with organs such as, for example, the intestine or the bladder. Asused herein, the term vessel is a broad term that can include any hollowor walled organ or structure of a living organism.

In some embodiments, an opening is formed in a wall of a blood vesseland at least a portion of a clamp device is inserted therein (see, e.g.,FIG. 4). The clamp device can capture and secure a portion of the bloodvessel wall (see, e.g., FIG. 7). A dilation device can be used to expandtissue surrounding the clamp device so as to expose a larger area of theblood vessel wall and create a tract through which an access device canbe inserted and moved to a position adjacent the vessel (see, e.g., FIG.11). A connection, approximation, or anastomosis actuation device can beconfigured to attach the access device to the vessel (see, e.g., FIGS.14-19). The clamping device, dilation device, and anastomosis actuationdevice can be removed from the patient upon completion of theanastomosis.

Certain embodiments are suitable for hemodialysis or similar procedures.In some embodiments, a conduit is anastomosed to a vessel and a proximalend thereof can be accessible outside of a patient's body. An obturatorcan be positioned within the conduit to maintain patency of theanastomosis and conduit. If desired, the obturator can be removed and ahemodialysis catheter can be inserted through the conduit into thepatient's vessel. The catheter may be connected to a hemodialysismachine and hemodialysis can be conducted. Upon completion of thehemodialysis, the catheter can be removed from the patient's vessel andentirely or partially removed from the conduit. The obturator can thenbe used to again occlude the anastomosis until further vascular accessis desired or required. In other embodiments, a port is anastomosed tothe blood vessel. The port can be implanted within the patient such thatno portion of it extends outside of the skin of the patient.

The term anastomosis is used broadly herein, and includes the ordinarymeaning of this term. In some cases, an anastomosis can be an operativeunion of two hollow or tubular structures, which can providesubstantially uninterrupted flow through the structures. In other cases,an anastomosis can act as a portal to selectively introduce one or moredevices, such as, for example, catheters or needles, from one tubularstructure into another. In some embodiments, the hollow or tubularstructure is relatively long and can extend percutaneously between theblood vessel and an exterior of a patient, whereas in other embodiments,the hollow or tubular structure that is anastomosed to the vessel can berelatively short and/or relatively small and can be fully implantedwithin the patient.

With reference to FIGS. 1 and 2, in certain embodiments, a clampassembly 100 can comprise an insertion or introducer tip 101, an anvil104, an anvil pull member 106, a clamp tube 109, and a clamp foot 110.As further discussed below, in certain embodiments, the introducer tip101 is connected to the anvil 104, which in turn is connected to theanvil pull member 106 such that movement of the anvil pull member 106effects movement of the introducer tip 101 and the anvil 104. The anvilpull member 106 and the clamp tube 109 can move independently of eachother. For example, in the illustrated embodiment, the anvil pull member106 is positioned within the clamp tube 109 and is substantially coaxialtherewith, and the anvil pull member 106 can slide or otherwise moveaxially relative to (e.g., telescopically within) the clamp tube 109.Relative movement of the anvil pull member 106 and the clamp tube 109can alter the relative spacing of the anvil 104 and the clamp foot 110.

With reference to FIGS. 1, 2, and 4, the introducer tip 101 can belocated at a distal end of the clamp assembly 100. The introducer tip101 can be flexible so as to readily deform to follow a lumen 50 of ablood vessel 51 once inserted therein, and it can be substantiallyatraumatic to an inner surface of a wall 53 of the vessel 51 so as to beable to follow the inner surface substantially without damaging the wall53. For example, in various embodiments, the introducer tip 101 cancomprise a flexible material such as polyurethane, thermoplasticelastomer, or silicone rubber. The introducer tip 101 can define atleast a portion of a lumen 102 of the clamp assembly 100 through which aguidewire 103 may pass. Accordingly, in some embodiments, the introducertip 101 can be inserted into the blood vessel 51 over the guidewire 103,and may bend or otherwise deform to follow a contour of the guidewire103 and/or a contour of the vessel wall 53.

An exterior surface 116 of the introducer tip 101 may be tapered in sucha manner that the introducer tip 101 provides its own dilation of skintissue 52 and the vessel wall 53. The tapered surface 116 of the tip canexpand from a relatively small diameter near a distal end of theintroducer tip 101 to a larger diameter at or near a proximal end of theintroducer tip 101, which can be adjacent the anvil 104. The term“diameter” is used broadly herein, and does not necessarily imply thatthe measured item is cylindrical or otherwise circularly symmetric. Forexample, the term can include the maximum transverse dimension of anitem, where the transverse dimension is defined as a distance betweentwo points on a periphery of the item, as measured along a straight linethat extends through a longitudinal axis of the item in a direction thatis substantially perpendicular to the longitudinal axis.

In certain embodiments, at least a portion of the introducer tip 101 isradiopaque. For example, in various embodiments, the introducer tip 101can comprise one or more radiopaque agents such as barium sulfate,bismuth trioxide, titanium dioxide, or the like. In other or furtherembodiments, the introducer tip 101 can be coated with a lubriciouscoating, such as a hydrophilic polymer, silicone oil, or other suitablelubricious material. The coating can facilitate a smooth passage of theintroducer tip 101 through the skin tissue 52, the vessel wall 53, andinto the vessel lumen 50.

With reference to FIG. 2, in some embodiments, the introducer tip 101 isconnected to the anvil 104. The introducer tip 101 can be secured to theanvil 104 utilizing a crimp band 118, adhesive, solvent bonding, and/orany other suitable technique. In various embodiments, the anvil 104 canbe made from a material comprising one or more of, for example, Delrin®(available from DuPont™ of Wilmington, Del.), polyurethane,polyvinylchloride, or other similar materials. The anvil 104 can bemanufactured using any suitable manufacturing method, such as, forexample, injection molding, machining, or casting. In some embodiments,the outer surface 116 of the introducer tip 101 can smoothly transitionto an outer surface of the anvil 104, which can facilitate insertion ofthe anvil 104 into the vessel lumen 50.

With continued reference to FIG. 2, in certain embodiments, a proximalsurface 105 of the anvil 104 is substantially flat or substantiallyplanar, and the plane defined thereby can be perpendicular to alongitudinal axis of the anvil 104. In some embodiments, a proximalportion of the anvil 104 can include a chamfer 117, which can extendaround all or substantially all of a periphery of the anvil 104. Thechamfer 117 is discussed further below. In other embodiments, theproximal surface 105 can be rounded (e.g., dome-shaped) or angled (e.g.,conical or frustoconical).

The anvil 104 can be generally hollow such that a distal portion of theclamp tube 109 can be received therein. In some embodiments, the anvil104 can receive a distal portion of the anvil pull tube 106 and thedistal end of the anvil 104 can be attached thereto. In the illustratedembodiment, the anvil 104 is attached to the anvil pull tube 106 via athreaded connection 127. In other or further embodiments, the anvil 104and the pull tube 106 can be attached to each other via an adhesive,welding, and/or in any other suitable manner. In some embodiments, theanvil 104 is over molded onto the distal end of the anvil pull tube 208.

The anvil pull tube 106 can be hollow so as to define at least a portionof the lumen 102, which can allow for the passage of the guidewire 103through the clamp assembly 100. The anvil pull tube 106 can besubstantially rigid and can have sufficient columnar strength to impartan insertion force to the introducer tip 101. The anvil pull tube 106can comprise stainless steel and/or any other suitable rigid material.

With reference to FIGS. 1 and 3, an extender tube 107 can be secured toa proximal end of the anvil pull tube 106. In various embodiments, thetube 107 can comprise plastic, such as, for example,polyetheretherketone (PEEK), and/or similar materials. In certainembodiments, a clutch 108 can be positioned at or near the connectionsite of the anvil pull tube 106 and the extender tube 107, or it canitself serve as a connector between the tubes 106, 107. The clutch 108can include a proximal shoulder 119 and a distal shoulder 124. Theclutch 108 can be made of any suitable material, such as one or more ofPEEK, metal, or the like. The clutch 108 can be attached to the proximalend of the anvil pull tube 106 in any suitable manner, such as, forexample, via a threaded connection and/or an adhesive. In otherembodiments, the extender tube 107 can be eliminated. For example, theanvil pull tube 106 can itself extend proximally beyond the clutch 108.

With reference to FIGS. 1-3, the clamp tube 109 can be positioned overor outside of the anvil pull tube 106. In some embodiments, an innerdiameter of the clamp tube 109 is only slightly larger than an outerdiameter of the anvil pull tube 106 such that the tubes 106, 109 are insliding engagement with each other, and contacting surfaces or theinterface of the tubes 106, 109 can be relatively resistant to thepassage of air or fluid thereby. In other embodiments, the innerdiameter of the clamp tube 109 is sufficiently larger than the outerdiameter of the anvil pull tube 106 such that friction between the tubes106, 109 is reduced or eliminated. For example, in the illustratedembodiment, the tubes 106, 109 define a channel 113 through which airand/or fluid may be conducted, as further discussed below. In theillustrated embodiment, the channel 113 is substantially annular due tothe substantially concentric cylindrical structures of the clamp tube109 and the anvil pull member 106. Other arrangements are possible

As shown in FIG. 2, the clamp tube 109 can include a clamp foot 110 ator near its distal end. The clamp foot 110 can be substantiallydisk-shaped and can have a larger diameter than more proximal portionsof the clamp tube 109. In some embodiments, the clamp foot 110 isintegrally formed with the clamp tube 109. In the illustratedembodiment, the clamp foot 110 extends radially outwardly from aproximal end of a clamp foot body 137 that is securely attached to theclamp tube 109. As further discussed below, in some embodiments, theclamp foot 110 can include one or more openings or notches 134 therein(see FIGS. 4, 5, and 7).

With reference to FIGS. 1 and 3, in some embodiments, a clamp actuationdevice 120 can be selectively positioned over a portion of the clampassembly 100. In some embodiments, the clamp actuation device 120 caninclude a housing 135 that is configured to be slid or otherwise movedover a proximal end of the clamp assembly 100 (e.g., over the tube 107)and into a secured position. In certain embodiments, the housing 135 issized and shaped to be gripped as a handle. The clamp actuation device120 can be releasably secured (e.g., selectively fixedly attached) tothe clamp tube 109 in any suitable manner such that the clamp actuationdevice 120 and the clamp tube 109 are substantially stationary relativeto each other when in a secured orientation.

In the illustrated embodiment, selective engagement and disengagement ofthe clamp actuation device 120 to and from the clamp tube 109 isachieved via an engagement actuator 125, such as a button. In theillustrated embodiment, the actuator 125 is coupled with a biasingelement 130, such as a compressed spring, that urges the actuator 125away from a longitudinal axis of the clamp actuation device 120. In someembodiments, when the actuator 125 is in a natural or non-actuatedstate, it protrudes through a base wall of the housing 135 such that auser can manipulate the actuator 125 by depressing it inwardly towardthe longitudinal axis of the housing 135. In some embodiments, anopening is defined through the actuator 125, and depressing the actuator125 inwardly against the bias of the biasing element 130 aligns theopening with a channel 131 defined by the housing 135, thereby openingthe channel 131 to allow the proximal end of the clamp assembly 100 topass through the channel 131 in a proximal direction. In someembodiments, the clamp tube 109 includes a notch or depression 126 thatextends inwardly toward a central axis of the clamp tube 109. Theactuator 125 can be released such that the biasing element 130 urges aportion of the actuator 125 into the clamp tube depression 126 tothereby secure the clamp actuation device 120 in place. To remove theclamp actuation device 120, the actuator 125 can be depressed to alignthe opening thereof with the channel 131, and the clamp actuation device120 can be moved in a proximal direction and removed over the proximalend of the clamp assembly 100. Other suitable arrangements of theactuator 125 are possible.

The clamp actuation device 120 can include a clamp actuator 121, whichin the illustrated embodiment comprises a lever having an outer arm 122and an inner arm 123 that are pivotally coupled to each other. The clampactuator 121 can be moved between an open or accessible state and aclamped, approximated, or closed state, which can move the clampassembly 100 between an open or accessible orientation and a clamped,approximated, or closed orientation, respectively. In the illustratedembodiment, the clamp actuator 121 is in the open state when the outerarm 122 is rotated forward toward a distal end of the clamp actuationdevice 120 and is in the closed state when the outer arm 122 is rotatedrearward toward a proximal end of the clamp actuation device 120 (i.e.,rotated to the position illustrated in FIGS. 1 and 3).

With reference to FIG. 3, in some embodiments, a biasing element 111 canbe configured to bias the anvil pull member 106 proximally relative tothe clamp actuation device 120. In the illustrated embodiment, thebiasing element 111 comprises a compression spring. A distal end of thebiasing element 111 is positioned at and/or is secured to the proximalend of the clamp tube 109. As previously mentioned, the clutch 108 canbe secured to the anvil pull member 106, and a distal end of the clutch108 can be positioned at and/or secured to the proximal end of thebiasing element 111. Accordingly, the biasing element 111 can provide aproximally directed biasing force on the clutch 108, and hence on theanvil pull member 106. The biasing force can in turn urge the anvil 104toward the clamp foot 110 (see FIG. 2).

In the illustrated embodiment, moving the actuator 121 from the closedstate to the open state comprises rotating the outer arm 122 forwardly,which causes the inner arm 123 to engage or contact the distal shoulder124 of the clutch 108. Continued forward rotation of the outer arm 122can cause the inner arm 123 to urge the clutch 108, and hence the anvilpull member 106, distally against the bias provided by the biasingelement 111.

With reference to FIG. 2, such distal movement of the anvil pull member106 can cause the anvil 104 to move distally away from a clamp foot 110,and can thereby create, or can broaden or widen, an opening or gap 132between the anvil 104 and the clamp foot 110 when the actuator 121 is inthe open state. The gap 132 can be reduced in size or closed by movementof the actuator 121 to the closed state.

In other embodiments, the distal end of the biasing element 111 can beattached directly to the clamp actuation device 120 (e.g., to thehousing 135) and may or may not be at or near the proximal end of theclamp tube 109. In still other embodiments, the anvil pull member 106can be selectively fixed relative to the clamp actuation device 120 suchthat actuation of the actuator 121 effects movement of the clamp tube109 relative to the anvil pull member 106. The actuator 121 thus canmove the clamp foot 110 relative to the anvil 104. For example, in someembodiments, when the actuator 121 is moved from the closed position tothe open position, the clamp foot 110 is moved away from the anvil 104in a proximal direction, thereby creating or broadening the gap 132between the clamp foot 110 and the anvil 104.

Referring, for example, to FIGS. 2, 5, and 6, in some embodiments, theclamp assembly 100 includes one or more teeth 115 that extendproximally. The teeth 115 can have one or more sharp or pointed ends or,in some embodiments, barbs (see FIG. 5), that can penetrate into orotherwise engage the vessel wall 53. The teeth 115 can comprise one ormore of a variety of materials, including, for example, stainless steel,Nitinol, or the like.

As shown in FIG. 2, in the illustrated embodiment, the teeth 115 extendproximally from a ring or tubular structure 133, and the tubularstructure 133 is coupled with the clamp tube 109 such that the tubularstructure 133 is fixed relative thereto and moves therewith. As shown inFIGS. 5 and 6, one or more of the teeth 115 can be configured to flexoutwardly. For example, in some embodiments, one or more of the teeth115 can be bent outwardly or otherwise biased toward a radially expandedstate during manufacture. The teeth 115 can be received within the anvil104 into a compressed state when the clamp foot 110 and the anvil 104are in close proximity. When the anvil 104 and the clamp foot 110 areseparated to create or expand the gap 132, the teeth 115 (or a portionthereof) can emerge from a position within the anvil 104 so as to expandoutwardly to their natural, preconditioned, or expanded state. Statedotherwise, movement of the anvil 104 and the clamp foot 110 away fromeach other can remove a restriction provided by the anvil 104 thatmaintains the teeth 115 in a constricted arrangement, thus permittingthe teeth 115 to flex outwardly to their natural expanded configuration.In various embodiments, the teeth comprise a shape memory material orsuper elastic metal alloy, such as, for example, Nitinol.

In other embodiments, a position or orientation of the teeth 115relative to either the anvil pull tube 106 or the clamp tube 109 may besubstantially fixed such that the teeth do not expand or contract as theclamp assembly 100 is moved between the open and closed states. In stillother embodiments, the clamp assembly 100 may be devoid of teeth 115.For example, other friction enhancing features may be applied to theanvil 104 and/or the clamp foot 110, and/or the shape and relativeorientations of the anvil 104 and the clamp foot 110 can providesufficient gripping of the vessel wall 53 throughout an anastomosisprocedure.

With reference again to FIGS. 2, 5, and 6, in some embodiments, the tipsof the teeth 115 are relatively close to the clamp foot 110 when theclamp foot 110 and the anvil 104 are in a closed or approximatedorientation. Moving the clamp foot 110 and the anvil 104 to the openposition so as to effect expansion of the teeth 115 can cause the tipsof the teeth 115 to move away from the clamp foot 110 in a radialdirection (e.g., away from a longitudinal axis of the assembly 100)and/or in an axial direction (e.g., distally). Such movement of theteeth 115 can provide access to sharpened ends thereof. The expandedconfiguration of the teeth 115 can facilitate improved capture of thevessel wall 53 in the gap 132 between the anvil 104 and the clamp foot110.

In other embodiments, the teeth 115 are fixed relative to the anvil 104.For example, in some embodiments the tubular structure 133 is attachedto the anvil 104. The teeth 115 can define an inner periphery that issized and shaped to receive an outer periphery of the clamp foot 110.For example, in some embodiments, the teeth 115 form a ring around theclamp foot 110 when the clamp foot 110 and the anvil 104 are in theclosed or approximated state. When the clamp foot 110 and the anvil 104are moved to the separated or open state so as to create the gap 132,the teeth 115 can maintain their original position relative to the anvil104. Due to the greater exposure of the tips of the teeth 115, suchmovement can allow the teeth 115 to grip, capture, embed within, orotherwise hold a portion of the vessel wall 53 that is introduced intothe gap 132 (e.g., the movement can provide access to tips of the teeth115). Certain of such embodiments can be formed by attaching the tubularstructure 133 in FIG. 2 to the anvil 104 rather than the clamp foot body137, by slightly reducing the diameter of the clamp foot 110, and byextending the teeth 115 in a proximal direction such that the tipsthereof encircle the clamp foot 110 when the clamp assembly 100 is inthe closed state.

With reference to FIG. 2, in some embodiments, one or more holes oropenings 112 through a wall of the clamp tube 109 can be provided. Theopenings 112 can extend through the clamp foot body 137 at a positiondistal of the clamp foot 110, and may be sized to permit bodily fluids(e.g., blood) or air to flow from the outside of the clamp tube 109 intothe channel 113 between the anvil pull member 106 and the clamp tube109. As shown in FIG. 4, at least a portion of the one or more openings112 can be exposed (e.g., can be positioned within the gap 132) when theclamp assembly 100 is in the closed or approximated orientation. In someembodiments, the notches 134 in the clamp foot 110 can improve bloodflow into the one or more openings 112. In other embodiments, the one ormore openings 112 can be fully enclosed by the anvil 104 when the clampassembly 100 is in the closed or approximated position. For example,this can be the case for certain of the embodiments described at the endof the previous paragraph, in which the tips of the teeth 115 encirclethe clamp foot 110 when the clamp assembly 100 is in the closed state.In such embodiments, the notches 134 can provide a channel through whichblood can flow from outside of the anvil 104 and the clamp foot 110 intothe openings 112 and the channel 113.

With reference to FIG. 3, the channel 113 can extend to a proximal endof the clamp tube 109. In some embodiments, a sealing member 136 sealsthe proximal end of the channel 113. The sealing member 136 can beconfigured to provide a substantially liquid-tight or airtight sealwhile permitting relative movement of the clamp tube 109 and the anvilpull member 106. In the illustrated embodiment, the sealing member 136comprises an o-ring.

One or more openings 114 in the clamp tube 109 can provide fluidcommunication between the channel 113 and a bodily fluid marker chamber129 defined by the housing 135. The bodily fluid marker chamber 129 canbe in fluid communication with a tube 74 having a connector 75 at an endthereof. The tube 74 can define a channel 72 that provides fluidcommunication between the bodily fluid marker chamber 129 and theconnector 75. In some embodiments, sealing devices 128, such as, forexample, o-rings, can create a seal around the clamp tube 109 at eitherside of the holes 114, and thus can prevent the blood or air fromleaking from the bodily fluid marker chamber 129 into other portions ofthe channel 131 defined by the housing 135.

A bodily fluid, such as blood from a blood vessel, or air can be drawnto the exterior of the clamp actuation device 120 via the channel 113,the bodily fluid marker chamber 129, and the tube channel 72 so as to bevisualized as a bodily fluid marker by a clinician. Such bodily fluidmarker visualization can be advantageous when the location of the anvil104 and the clamp foot 110 relative to a vessel wall is not visuallyobservable by a user of the clamp assembly 100, as the skin of a patientor the vessel wall itself may obscure the location of the anvil 104 andthe clamp foot 110. In such cases, the bodily fluid marker can functionas a method to confirm the location of the anvil 104 and the clamp foot110, as further discussed below.

In certain embodiments, in order to draw blood (in the case of a bloodvessel) or some other bodily fluid for visualization, negative pressurecan be applied to the channel 113 via the connector 75. For example, asyringe (not shown) can be connected to the connector 75 and a plungerof the syringe withdrawn in order to create negative pressure sufficientto draw blood through the bodily fluid marker chamber 129 forvisualization. Other suitable methods for applying negative pressure viathe connector 75 so as to visualize the presence of blood or air in thevicinity of the clamp foot 110 are also possible.

Methods for clamping the vessel wall 53 can include positioning theguidewire 103 within a target blood vessel 51 utilizing a well knownmicropuncture technique for vascular access. The insertion tract aroundthe guidewire 103 can be dilated (e.g., serially dilated). As shown inFIG. 4, the clamp assembly 100 can then be passed over a proximal end ofthe guidewire 103 via the lumen 102. The clamp assembly 100 can beinserted through the skin tissue 52, the vessel wall 53 and into thelumen 52 of the target vessel 51 over the guidewire 103.

In certain embodiments, it can be desirable for the clamp assembly 100to be in the closed or approximated state during its insertion into theblood vessel 51. As previously discussed, the tips of the teeth 115 canbe relatively inaccessible when the clamp assembly 100 is closed. Thetips thus are less likely to inadvertently capture the tissue 52 as theclamp assembly 100 is inserted into the blood vessel 51. In someembodiments, it can be desirable to ensure that the clamp assembly 100remains closed during insertion. In certain of such embodiments, theclamp foot 110 can be inserted into the blood vessel 51 as the clampassembly 100 remains closed during the insertion. Although the clampfoot 110 can have a larger diameter than the portion of the clamp tube109 that is proximal thereto, the vessel wall 53 can be sufficientlyresilient to close around the clamp tube 109 after the clamp foot 110has passed through the wall 53 into the vessel 51, as shown in FIG. 4.The interface between the vessel wall 53 and the clamp tube 109 thus cansubstantially prevent egress of blood from the vessel 51.

With continued reference to FIG. 4, when the clamp foot 110 is insidethe vessel lumen 50, blood can be withdrawn from the vessel 51 throughthe openings 112. Withdrawal of blood, rather than air, can indicatethat the clamp assembly 100 is in a desirable position for opening. Theclamp actuator 121 can then be moved to the open position, therebymoving the anvil 104 distally away from the clamp foot 110. The gap 132thus can be enlarged (as in the illustrated embodiment) or created, andaccess to the teeth 115 can be provided.

In some embodiments, it is possible to properly position the clampassembly 100 for clamping the vessel wall 53 without fully, or evenpartially, inserting the clamp foot 110 through the vessel wall 53 orinto the vessel lumen 50. For example, in the illustrated embodiment,the openings 112 can be within the lumen 50 when a distal surface of theclamp foot 110 is substantially even with an inner surface of the vesselwall 53. At such a stage of insertion of the clamp assembly 100, bloodcan be withdrawn from the vessel 51 via the channel 113 so as toindicate that the clamp assembly 100 can be moved to the openconfiguration.

With reference to FIGS. 5 and 6, the clamp assembly 100 can remain inthe open configuration and can be moved proximally so as to pull theclamp foot 110 and the anvil 104 toward the vessel wall 53. In someembodiments, once the clamp foot 110 has passed through the vessel wall53 in a proximal direction, the vessel wall 53 can resiliently closearound the clamp foot body 137 within the region of the gap 132. In someembodiments, it can be desirable for the clamp foot body 137 to have aslightly enlarged diameter of sufficient size to allow the vessel wall53 to resiliently close in around and contact it around substantiallythe full periphery of the clamp foot body 137. This can aid in properlycentering and positioning the vessel wall 53 for subsequent cutting.Additional proximal movement of the clamp assembly 100 can cause thevessel wall 53 to be captured or otherwise retained on the teeth 115.Such capturing of the vessel wall 53 can be sensed by an operator of theclamp actuation device 120 as an increased resistance to proximalmovement of the clamp assembly 100, which increased resistance can beprovided by the blood vessel 51. In some embodiments, another indicatorthat the vessel wall 53 has been captured can be the stoppage of bloodflow through the channel 113 and/or an initiation of air flow throughthe channel 113, which can occur if the openings 112 are sufficientlysmall and/or are spaced sufficiently far from the anvil 104 so as to nolonger be positioned within the lumen 50 of the vessel 51 when thevessel wall 53 has been captured.

With reference to FIGS. 7 and 8, once the vessel wall 53 has beencaptured on the teeth 115, the clamp actuator 121 (see FIG. 3) can bemoved to the closed state, thereby permitting the anvil 104 to moveproximally under the bias provided by the biasing member 111 (see FIG.3) toward the clamp foot 110. As the anvil 104 sheaths increasinglygreater portions of the teeth 115, the teeth 115 can be move or rotatedradially inward so as to return to a constricted configuration. As aresult, a portion of the vessel wall 53 that was captured within aperiphery defined by the sharpened tips of the teeth 115 can beconstricted or drawn inward toward a longitudinal axis of the clampassembly 100. As previously discussed, in other embodiments, the teeth115 do not expand and contract as the clamp assembly 100 is opened andclosed, respectively, such that a periphery of a captured portion of thevessel wall 53 may remain substantially constant during closure of theclamp assembly 100. In either case, closure of the clamp assembly 100can be clamped, or securely hold, the vessel wall 53 between the anvil104 and the clamp foot 110.

In some embodiments, the guide wire 103 is removed from the vessel 51through the clamp assembly 100 once the vessel wall 53 has been clamped.In other embodiments, the guide wire 103 can be removed at some otherstage of an anastomosis procedure. With reference to FIG. 3, once thevessel wall 53 has been clamped, the actuator 125 can be depressed andthe clamp actuation device 120 can be moved in a proximal direction andremoved from the clamp assembly 100. As further discussed below, theclamp actuation device 120 can be replaced with an anastomosis actuationdevice 300 for addition stages of an anastomosis procedure.

With reference to FIG. 9, in some embodiments, a dilation device, tractdilation assembly, or tract dilator 200 can be positioned over the clampassembly 100. In some embodiments, the tract dilator 200 can bepositioned over the clamp assembly 100 after the vessel wall 53 has beenclamped and after the clamp actuation device 120 has been removed fromthe clamp assembly 100. Such an arrangement is illustrated in FIGS. 1-8,as the tract dilator 200 is not present during the clamping of the bloodvessel wall 53.

In other embodiments, such as the embodiment illustrated in FIGS. 9-11,both the clamp actuation device 120 and the tract dilator 200 can bepositioned over the actuation assembly 100 during the clamping of thevessel wall 53. The tract dilator 200 can be at a position that isdistal of the clamp actuation device 120. In some embodiments, the clampactuation device 120 is separable from the tract dilator 200, whereas inother embodiments, the tract dilator 200 and the clamp tube handle 120are securely attached to each other, or can define an integral unit.With reference to FIG. 9, in the illustrated embodiment, the tractdilator 200 defines an alignment channel 205 sized and shaped to receivetherein a distal nose 138 of the clamp actuation device 120 (see alsoFIG. 1). The distal nose 138 and the alignment channel 205 can cooperateto define a longitudinal axis that is common to both the clamp actuationdevice 120 and the tract dilator 200. The clamp actuation device 120 canbe friction fit to or otherwise selectively or temporarily coupled withthe tract dilator 200.

The tract dilator 200 can include one or more legs 201 that areconfigured to move from a closed, contracted, or constricted state(e.g., FIGS. 9 and 10) to an open or expanded state (e.g., FIG. 11) inorder to expand the size of an insertion tract 55 through the skintissue 52 and thereby provide greater access to the blood vessel 51. Inthe illustrated embodiment, the tract dilator 200 includes three legs201, which are shown in the various views of FIGS. 9-11. More or fewerlegs 201 are possible. For example, in various embodiments, the tractdilator 200 includes two or more legs 201, three or more legs 201, fouror more legs 201, or five or more legs 201.

With reference to FIGS. 9 and 10, when the legs 201 are in the closed orconstricted state, they can extend substantially parallel to alongitudinal axis of the clamp assembly 100, and the distal ends thereofcan be adjacent the clamp foot 110. As shown in FIG. 10, in someembodiments, the distal end of each leg 201 includes a recess ordepression 207. Together, the depressions 207 can define a cavity at aproximal end of the clamp foot 110. The cavity can be sized to receivethe clamp foot 110 therein such that the distal ends of the legs 201 canmore closely approach or contact the vessel wall 53, which can aid indisplacement of adventitia from the vessel wall 53 when the legs aremoved to the expanded state. The distal ends of the legs 201 can definenotches 202 or other suitable engaging features, which can catch or gripthe tissue 52 as the legs are radially expanded and can aid in securingthe dilation device 200 in a substantially fixed position during ananastomosis procedure.

An outer surface 203 of the legs 201 can be radiused, and the legs 201can fit closely together to form a substantially smooth or substantiallycontinuous structure that surrounds or encircles the clamp assembly 100when the legs 201 are in the constricted state. A distal portion of thestructure formed by the legs 201 can have a diameter that is about thesame size as the diameter of the anvil 104, in some embodiments, orslightly smaller than the diameter of the anvil 104 in otherembodiments, which can facilitate insertion of the legs 201 into theskin tissue 52. In some embodiments, the distal ends of the legs 201 canbe inserted into the vessel lumen during the initial insertion of theclamp assembly 100 into the vessel. Accordingly, the size and shape ofthe distal ends of the legs 201 can facilitate such insertion into thevessel. Insertion of the distal ends of the legs 201 can aid inpositioning the legs 201 sufficiently close to the vessel wall to clearaway the skin tissue 52.

The diameter at the distal end of the legs 201 can be smaller than adiameter than the proximal portion thereof. For example, in someembodiments, an outer surface 203 of the legs 201 can be tapered outwardsuch that the legs 201 increase in thickness from a distal end to aproximal end thereof. The larger thickness of the proximal portion ofthe legs 201 can increase their flex strength. The legs 201 can be madefrom any suitable rigid material, such as, for example, stainless steel.

In some embodiments, a thin tearable sheath (not shown) can surround thedistal portion of the legs. The sheath can prevent or inhibitinadvertent radial expansion of the legs 201 and can facilitate a smoothinsertion of the legs 201 into the insertion tract 55. The sheath can bemade from heat shrink tubing. In some embodiments, the legs 201 can becoated with a lubricant, such as, for example, a hydrophilic polymer orsilicone oil, to facilitate their smooth insertion through the insertiontract 55.

With reference to FIGS. 9 and 11, in some embodiments, the tract dilator200 comprises a dilation actuator 220 configured to move the legs 201between the constricted state and the expanded state. Any suitable formof dilation actuator 220 may be used to alter the orientation of thelegs 201. In the illustrated embodiment, a distal end of each leg 201 ispivotally coupled to an arm 221 at a pivot point 226, and each arm 221is pivotally coupled to a distal housing 222 at a pivot point 227. Alsocoupled to the distal housing 222 is a proximal housing 225. The distaland proximal housings 222, 225 are coupled to each other via a threadedinterface 228 so as to be able to rotate and translate relative to eachother about and along a central axis of the tract dilator 200. In someembodiments, the distal and proximal housings 222, 225 are sized andshaped to be gripped as handles, and can include surface features, suchas grooves, to aid with the gripping. The proximal housing 225 caninclude a cam surface 224 that tapers inwardly toward a central axis ofthe dilator device 200 in a proximal direction.

As shown in FIG. 9, when the legs 203 are in the constricted state, theproximal ends of the arms 221, which can be rounded or radiused, contacta distal end of the cam surface 224. The proximal housing 225 can berotated about the central axis of the dilator device 200 so as to beadvanced distally along the threaded interface 228, which likewiseadvances the cam surface 224 in a distal direction. As shown in FIG. 11,the decreasing diameter or inward slope of the cam surface 224 urges theproximal ends of the arms 221 radially inward, thereby causing the arms221 to pivot about the pivot points 227 such that the distal ends of thearms 221 move radially outwardly. The outward movement of the distalends of the arms 221 can urge the legs 201 radially outwardly, therebycompressing or otherwise moving the skin tissue 52 outwardly to expandthe insertion tract 55. The skin tissue 52 can resist the expansion ofthe insertion tract 55, thereby applying an inward force on the distalends of the legs 201. This inward force can cause the legs 201 to pivotsomewhat about the pivot point 226. As a result of this latter pivoting,the insertion tract 55 can have a more uniform cross sectional area (ina direction transverse to a longitudinal axis of the clamp assembly 100)than it would otherwise.

A geometry of the expanded insertion tract 55 can depend on the numberand configuration of the legs 201. In the illustrated embodiment, thethree legs 201 form an expanded insertion tract 55 shaped substantiallyas the base of a triangular pyramid. In other embodiments, the expandedinsertion tract 55 can resemble the base of a square pyramid, such aswhen four legs 201 are used. In still further embodiments, use ofadditional legs 201 can result in the expanded insertion tract 55 moreclosely resembling a base of a cone. As shown in FIG. 11, the insertiontract 55 can be wider at a distal end of the legs 201 (e.g., at or nearthe vessel wall 53) than at a more proximal portion thereof. In variousembodiments, a maximum diameter of the expanded insertion tract 55 canbe between about 12 French and about 30 French, no less than about 12French, no less than about 15 French, no less than about 20 French, orno less than about 30 French.

Movement of the legs 201 to the expanded orientation can distance theproximal ends of the legs 201 from the clamp assembly 100, which canopen an insertion corridor 229 between the legs 201 and the clampassembly 100. As discussed further below, a periphery of the corridor229, which can be defined by the proximal ends of the legs 201, can besufficiently large to allow passage of a distal end of an anastomosisactuation device 300 (see FIG. 12) through it toward the vessel wall 53.

In use, embodiments of the tract dilator 200 can be positioned over theclamp assembly 100 such that the distal end of the legs 201 are adjacentthe clamp foot 110. The clamp assembly 100 can be inserted into thevessel 51 and the vessel wall 53 can be clamped in a manner describedabove. Due to the positioning of the tract dilator 200 relative to theclamp assembly 100, insertion of the clamp assembly 100 into the vessel51 and insertion of the tract dilator 200 into the skin tissue 52 cantake place at the same time or during the same stage. As previouslydiscussed, however, in other embodiments, the tract dilator 200 can beinserted into the skin tissue 52 subsequent to clamping the vessel wall53 via the clamp assembly 100. In either case, when the legs 201 arewithin the insertion tract 55, the dilation actuator 220 can beactuated. For example, as previously discussed, the proximal housing 225can be rotated relative to the distal housing 222, thereby causing thecam surface 224 to move distally and drive the proximal ends of the arms221 radially inward and the distal ends of the legs 201 radially outwardto dilate the insertion tract 55.

In certain embodiments, once the insertion tract 55 is dilated, theclamp actuation device 120 can be removed from the clamp assembly 100(in a manner such as discussed above) and replaced with an anastomosisactuation device 300, an embodiment of which is illustrated in FIG. 12.The anastomosis actuation device 300 can be used to attach an accessdevice to the blood vessel 51. The access device can comprise a conduit318 that is anastomosed to the blood vessel 51 in an end-to-sideanastomosis, and the conduit 318 can extend through the skin tissue 52so as to be accessible from a position outside of the patient once theanastomosis procedure is complete (see FIG. 17). In other embodiments,the anastomosis actuation device 300 can be configured to implant anaccess device, such as an anastomosis implant 918, beneath or within theskin tissue 52 (see FIG. 40).

With reference to FIG. 12, in certain embodiments, the anastomosisactuation device 300 comprises a housing 302, which can be sized andshaped to be gripped as a handle. The housing 302 can include a distalnose 338, which can be configured substantially identically to thedistal nose 138 of the clamp actuation device 120. Accordingly, thedistal nose 338 of the anastomosis actuation device 300 can be receivedwithin the alignment channel 205 of the tract dilator 200 in anysuitable manner, such as those described above with respect to thedistal nose 138 of the clamp actuation device 120 (see FIG. 9).

An adapter tube 303 can be fixedly attached to the housing 302 so as tobe substantially stationary relative thereto. An approximation tube oractuator tube 311 can be positioned within the adapter tube 303, and maybe coaxial therewith. The actuator tube 311 can be configured to moverelative to the adapter tube 303. For example, the actuator tube 311 canbe configured to move from an initial or un-actuated position to one ormore distal positions, such as a region of approximation and an ejectionposition, which are discussed further below. Depending on the relativeinner diameter of the adapter tube 303 and the outer diameter of theactuator tube 311, the tubes 303, 311 can be in sliding engagement witheach other, or they may be sufficiently radially spaced from one anotherto move relative to each other without frictional engagement.

A cutter tube 309 can be positioned within the actuator tube 311. In theillustrated embodiment, the cutter tube 309 is fixedly attached to thehousing 302 at its proximal end. A distal end of the cutter tube 309 canhave a sharpened blade 310, which is discussed further below (see also,e.g., FIG. 16). In some embodiments, the blade 310 extends distallybeyond a distal end of the adapter tube 303. However, a retainingadapter 304, which can also be referred to as a temporary retainer, canbe fixedly attached to the distal end of the adapter tube 303, and theretaining adapter 304 thus can extend distally beyond the blade 310 soas to substantially shield or encircle the blade 310. A conduit 318 (seeFIG. 15) can be positioned within the adapter tube 303, and further, canbe positioned between the actuator tube 311 and the cutter tube 309 (seeFIG. 16). However, for clarity, the conduit 318 is not shown in FIG. 12.Likewise, the clamp assembly 100 can be received within the anastomosisactuation device 300, but is not shown in FIG. 12 for the sake ofclarity. In the illustrated embodiment, the clamp assembly 100 can bepositioned within the cutter tube 309 and can extend through a channel344 defined by the housing 302.

The anastomosis actuation device 300 can include a cutter actuator 320,which can include any suitable arrangement of structures configured tocooperate to effect movement of a clutch coupler or clutch coupling tube340. In the illustrated embodiment, the cutter actuator 320 includes anouter lever 337 that is pivotally coupled to one or more inner links339. A locking or compression member 339 a, such as one or moreBellville washers, can be positioned between an inner link 339 and adistal end of the clutch coupling tube 340. A biasing device 341, suchas a compression spring, can be positioned at a proximal end of theclutch coupling tube 340. The biasing device 341 can be secured to orotherwise contact the housing 302 at its proximal end. The clutchcoupling tube 340 can include a catch member 342, which can include aliving hinge or a biased finger that extends radially inwardly toward alongitudinal axis of the clutch coupling tube 340.

As previously discussed, the anastomosis actuation device 300 canreplace the clamp actuation device 120 once the clamp assembly 100 hasbeen coupled with a vessel wall 53. The anastomosis actuation device 300can be advanced in a distal direction over the clamp assembly 100 untilthe nose 338 of the housing 302 is received within the alignment channel205 of the tract dilator 200 and until the catch member 342 of theclutch coupling tube 340 is received within a recess of the clutch 108that is defined between the proximal and distal shoulders 119, 124thereof (see, e.g., FIG. 3).

When the anastomosis actuation device 300 is coupled to the clampassembly 100, the cutter actuator 320 can be moved from an un-actuatedor resting state to a cutting, embedding, or actuated state. In theillustrated embodiment, the cutter actuator 320 is in the resting statewhen the outer lever 337 is in a forward or distal position. The cutteractuator 320 can be moved to the actuated state by rotating the outerlever 337 in a proximal direction. In the illustrated embodiment, thehousing 302 defines a channel 343 at a proximal end thereof which canreceive the outer lever 337. Accordingly, the outer lever 337 can besubstantially parallel to a longitudinal axis of the clamp assembly 100when the cutter actuator 320 is actuated.

Movement of the cutter actuator 320 to the actuated state can cause theclutch coupling tube 340 to move proximally against a distally directedbias of the biasing member 341. In some embodiments, the cutter actuator320 can be locked or selectively maintained in the actuated position.For example, in the illustrated embodiment, when the cutter actuator 320is in the actuated state, the nearly parallel alignment of the outerlever 320 with the axially directed force of the biasing member 341 canreduce or eliminate any torque on the outer lever 337 that mightotherwise be provided by the links 339, which would tend to urge theouter lever 337 to move in a distal direction. Any other or additionalsuitable locking mechanism can be employed, such as, for example, one ormore of a detent and a latch.

The anastomosis actuation device 300 can include an approximation andejection actuator 330, also referred to as an approximation actuator330, which can include any suitable arrangement of structures configuredto cooperate to effect movement of a clutch 319. In the illustratedembodiment, the approximation actuator 330 includes an outer lever 345that is pivotally coupled to one or more inner links 346. At least oneof the inner links 346 can contact the clutch 319 so as to move it in adistal direction. In the illustrated embodiment, the clutch 319 definesa central bore through which the cutter tube 309 extends, and the clutch319 is configured to translate over the cutter tube 309.

The approximation actuator 330 can be moved from an un-actuated orresting state to an approximation stage, region or state, and further,can be moved from the approximation state to an ejection state. In someembodiments, transition from one state to another can be smooth orcontinuous, whereas in other embodiments, the different operationalstates can be discreet from each other (e.g., the outer lever 345 maytransition through one or more detents). In the illustrated embodiment,the approximation actuator 330 is in the resting state when the outerlever 345 is in a forward or distal position. The cutter actuator 320can be moved to the approximation state by rotating the outer lever 345in a proximal direction. In the illustrated embodiment, theapproximation state may first be reached when the outer lever 345 is atapproximately a right angle relative to a longitudinal axis of theactuator tube 311, or when a distal end of the clutch 319 first contactsthe actuator tube 311 and begins to move it in a distal direction. Thecutter actuator 320 can remain in the approximation state as the outerlever 345 is rotated proximally through additional angles and theactuator tube 311 is moved distally. The approximation actuator 330 cantransition to the ejection state when the outer lever 345 is proximallyrotated to an even greater extent such that the actuator tube 311 ismoved distally to an even greater extent. Angular orientations andarrangements for the outer lever 345 other than those just described arealso possible.

With reference to FIG. 13, in certain embodiments, the retaining adapter304 includes one or more retention channels 314. The retention channels314 can extend proximally from a distal end of the retaining adapter304, and may extend into a sidewall of the adapter. In the illustratedembodiment, the retaining adapter 304 includes four retention channels314, although more or fewer retention channels 314 are possible.

With reference to FIG. 14, in certain embodiments, an anastomosis clip305 can be configured to couple with the retaining adapter 304 in atemporary manner. For example, the anastomosis clip 305 can include oneor more retention legs 307 that can be received within the one or moreretention channels 314 of the retaining adapter 304 in a friction-fit orinterference-fit engagement. In the illustrated embodiment, theanastomosis clip 305 includes four retention legs 307, each of which canbe received in a separate retention channel 314. More or fewer retentionlegs 307 are possible.

The anastomosis clip 305 can also include one or more connection legs308. In some embodiments, the connection legs 308 are longer than theretention legs 307. Additionally, the connection legs 308 can be closerto an axial center of the anastomosis clip 305 than are the retentionlegs 307.

The anastomosis clip 305 can define a through hole 312 through which theclamp assembly 100, or at least a portion thereof, can pass. Theanastomosis clip 305 can include one or more teeth 306 surrounding athrough hole 312, which can extend proximally. The anastomosis clip 305can be made from any suitable material, such as, for example, stainlesssteel. In some embodiments, the anastomosis clip 305 is coated with anantithrombogenic, anti-inflammatory, or cell proliferation inhibitoragent, such as heparin or rapamycin.

With reference to FIG. 15, in certain embodiments, an anastomoticimplant or access device can include the conduit 318 through which bloodmay flow and/or through which blood access equipment may be passed afteranastomosis of the device to a blood vessel 51. The conduit 318 can besubstantially hollow, and can be made from any suitable material. Forexample, in various embodiments, the conduit 318 comprises one or morebiocompatible materials, such as, for example, polytetrafluoroethylene(PTFE), polyurethane, silicone rubber, or other similar materials. Theconduit 318, or at least a portion thereof, can be radiopaque. Forexample, one or more radiopaque agents, such as barium sulfate, bismuthtrioxide, titanium dioxide, or the like can be dispersed throughout theconduit or can be formed into one or more stripes.

In certain embodiments, the anastomosis adapter or conduit adapter 313is attached to a distal end of the conduit 318. The conduit adapter 313can include one or more connection channels 315 therein or therethrough.In the illustrated embodiment, the connection channels 315 extend fullythrough a peripheral edge of the conduit adapter 313. In the illustratedembodiment, the conduit adapter 313 comprises four connection channels315, each of which can receive one of the connection legs 308 of theanastomosis clip 305 in a friction-fit or interference-fit engagement.For example, in some embodiments, the connection channels 315 receiveproximal tips of the connection legs 308 in an interference fit, and thestrength of the interference fit is maintained or increased as theconnection legs 308 are forced deeper into the connection channels 315.In other embodiments, the interference fit is created only when theconnection legs 308 are fully inserted or nearly fully inserted into theconnection channels 315. In either case, the interference fit can retainthe anastomosis clip 305 and the conduit adapter 313 in a coupledarrangement, as further discussed below.

With continued reference to FIG. 15, the conduit adapter 313 can includeprojections or teeth 316 that extend in a distal direction. In someembodiments, when the connection legs 308 of the anastomosis clip 305are received within the connection channels 315 of the conduit adapter313, the teeth 316 of the conduit adapter 313 are rotationally offsetrelative to (e.g., are configured to interdigitate with) the teeth 306of the clip 305. As shown in FIG. 20, in some embodiments, the contoursof the teeth 316 of the conduit adapter 313 and the teeth 306 of theanastomosis clip 305 can be substantially complementary to each other.

FIG. 16 illustrates an embodiment of the anastomosis actuation device300 being coupled with the clamp assembly 100. The anastomosis actuationdevice 300 is being advanced distally over the clamp assembly 100, andalthough not shown in FIG. 16, the catch member 342 of the clutchcoupling tube 340 is about to be received in the recess between theproximal and distal shoulders 119, 124 of the clutch 108 (see FIGS. 3and 12). Also not shown are the legs 201 of the tract dilator 200, whichare maintaining the insertion tract 55 in an expanded state. Once theanastomosis actuation device 300 is fully coupled with the clampassembly 100, its distal end (i.e., the distal end of the retainingadapter 304) will be in closer proximity to the vessel wall 53.

Each of the clamp assembly 100 and the anastomosis actuation device 300are fully assembled. Accordingly, although they are not necessarilydiscussed at present, visible features previously discussed with respectto FIGS. 12-15 are identified in FIG. 16 for the sake of clarity. It canbe seen that in the illustrated embodiment, when the conduit 318 isincluded in the anastomosis actuation device 300, the conduit adapter313 frictionally engages an outer surface of the cutter tube 309. Theconduit 318 itself is positioned between the cutter tube 309 and theactuator tube 311, but it does not frictionally engage either tube 309,311. Accordingly, the conduit 318 is held in its pre-anastomosisposition primarily by the interaction between the conduit adapter 313and the cutter tube 309. A distal end of the actuator tube 311 can be incontact with or adjacent to a shoulder 317 of the conduit adapter 313.

Once the anastomosis actuation device 300 is fully coupled with theclamp assembly 100, the anvil pull tube 106 can be drawn in a proximaldirection via actuation of the cutter actuator 320, as previouslydiscussed. With the clamp assembly 100 being maintained in a closedconfiguration (e.g., due to the bias of the biasing member 111; see FIG.3), movement of the anvil pull tube 106 in the proximal direction cancause the clamp tube 109 to move in the proximal direction as well suchthat the clamp foot 110, the anvil 104, and the portion of the vesselwall 53 that is between the clamp foot 110 and the anvil 104 can bepulled into the anastomosis actuation device 300. In particular, theclamp foot 110, the anvil 104, and the clamped vessel wall 53 can moveproximally through the through hole 312 of the clip 305.

FIG. 17 illustrates a point in time just after the clamp assembly 100has been pulled into the anastomosis actuation device 300 sufficientlyfar for a cut portion 334 to have been severed from the vessel wall 53by the blade 310 of the cutter tube 309, or stated otherwise, just afterthe cutter actuator 320 has been moved into the actuated state. In someembodiments, the blade 310 can cut through the vessel wall 53 andcontact the proximal surface 105 of the anvil 104 or be embeddedtherein. In some embodiments, a circular hole in the vessel wall iscreated by the blade 310. Other shapes are also possible.

In other embodiments, the vessel wall 53 can be pulled through thethrough hole 312 of the clip 305, and the blade 310 can be advanced in adistal direction to cut the vessel wall 53. Accordingly, in someembodiments, the cutter tube 309 is not fixed relative to the housing.

With continued reference to FIG. 17, the portion of the vessel wall 53that is pulled into the retaining adapter 304 (e.g., drawn through thethrough hole 312 of the anastomosis clip 305) can surround an outersurface of the anvil 104. The close proximity of the teeth 306 of theanastomosis clip 305 to the outer surface of the anvil 104 can squeezethe vessel wall 53 and prevent it from retracting from the clip 105. Aperipheral edge 329 of the vessel wall 53, which results from thesevering of the cut portion 334, can surround or encircle the outersurface of the anvil 104, whereas a portion of the vessel wall 53 thatis more distal relative to the peripheral edge 329 of the vessel wall 53can be captured between the clip 305 and the anvil 104, as justdescribed. The cut portion 332 of the vessel wall 53 can remain in theclamp assembly 100 between the anvil 104 and the clamp foot 110. Aspreviously discussed, in some embodiments, the cutter actuator 320 canbe locked or selectively maintained in the actuated state, which in someinstances can facilitate subsequent stages of an anastomosis procedure.

With reference to FIG. 18, once the cut portion 334 has been severedfrom the vessel wall 53 so as to form an opening therein, anastomosis ofthe conduit 318 to the blood vessel 51 can be completed. Theapproximation actuator 330 (FIG. 12) can be moved from the resting stateto the approximation state. As previously discussed, such movement cancause the actuator tube 311 to move distally. As it does so, a distalend of the actuator tube 311 pushes against the shoulder 317 of theconduit adapter 313, thereby causing the conduit adapter 313 and theconduit 318 to move in the distal direction. The distal movement of theconduit adapter 313 results in the approximation of the conduit adapter313 to the clip 305. Stated otherwise, the conduit adapter 313 movesdistally and approaches the clip 305, which can result in the peripheraledge 329 of the vessel wall 53 everting over the teeth 306 of the clip305 and being captured between the interdigitated teeth 306 of clip 305and the teeth 316 of the conduit adapter 313 (see also FIG. 20).

Stated in yet another way, in the illustrated embodiment, an anastomosisbetween the conduit 318 and the blood vessel 51 can be accomplished byoutwardly everting, via the conduit adapter 313, the portion of thevessel wall 51 that surrounds the anvil 104. A close fit between aninner surface of the conduit adapter 313 and an outer surface of theanvil 104 can cause the peripheral portion 329 of the vessel wall thatsurrounds the anvil to be everted so as to move outwardly and distallyrelative to the teeth 306 of the anastomosis clip 305 as the conduitadapter 313 moves distally relative to, and is in close contact with,the outer surface of the of the anvil 104. As previously discussed, insome embodiments, the anvil 104 can have a chamfer 117 at the peripheryof its proximal end, which can aid in centering the conduit adapter 313over the anvil 104 as the conduit adapter is moved distally. In someembodiments, the teeth 316 are flexible, and may define a slightlysmaller diameter than the proximal surface of the anvil 104 such thatthey can effectively scoop the vessel wall away from the anvil 104.

In some embodiments, as the conduit adapter 313 is advanced distally,the connection legs 308 of the anastomosis clip 305 are advanced deeperinto the connection channels 315 of the conduit adapter 313. As aninterference is achieved, maintained, and/or increased between theconnection legs 308 of the anastomosis clip 305 and the connectionchannels 315 of the conduit adapter 313, the anastomosis clip 305 issubstantially fixed relative to the retaining adapter 304 due to theexisting interference between the retention legs 307 of the anastomosisclip 305 and the retention channels 314 of the retaining adapter 304(see FIGS. 13 and 14). As discussed above, the everted tissue 329 iscaptured between the teeth 306 of the anastomosis clip 305 and the teeth316 of the conduit adapter 313, which can create a hemostatic sealbetween the conduit adapter 313 (and hence the conduit 318) and thevessel wall 53.

With reference to FIG. 19, as additional distally directed force isapplied to the conduit adapter 313 via the actuator tube 311, or statedotherwise, as the approximation actuator 330 is moved through theapproximation state to the ejection state, the retention legs 307 of theanastomosis clip 305 are eventually forced out of the retention channels314 of the retaining adapter 304 (see FIGS. 13 and 14). In someembodiments, the force required to friction fit or otherwise attach theconnection legs 308 of the anastomosis clip 305 to the connectionchannels 315 of the conduit adapter 313 is less than the force requiredto disengage the retention legs 307 of the anastomosis clip 305 from theretention channels 314 of the retaining adapter 304. In furtherembodiments, the force required to disengage the retention legs 307 ofthe anastomosis clip 305 from the retention channels 314 of theretaining adapter 304 is less than the force required to puncture orsever the vessel wall 53 via one or more teeth 306, 316 or otherwisecompromise the hemostatic seal formed by the anastomosis clip 305 andthe conduit adapter 313.

Once the anatomosis of the conduit 318 to the blood vessel 51 iscomplete, the anastomosis actuation device 300 and clamp assembly 100can be removed from the insertion tract 55. With reference again toFIGS. 9 and 11, either before or after removal of the anastomosisactuation device 300 and the clamp assembly 100, the insertion tract 55can be allowed to close by rotating the proximal housing 225 relative tothe distal housing 222 of the tract dilator 200 such that the camsurface 224 moves in a proximal direction, thereby releasing a radialconstriction on the proximal ends of the arms 221. With the insertiontract 55 in a closed or constricted configuration, the tract dilator 200can be removed therefrom.

FIG. 20 illustrates the conduit 318 after the anastomosis procedure. Asshown, the conduit 318 can provide a passageway that extends through theskin tissue 52 between the blood vessel 51 and a position outside of theskin tissue 52.

Other configurations and processes than those discussed above withrespect to the anastomosis actuation device 300 are also possible. Forexample, in some embodiments, the anastomosis actuation device 300 cancomprise spring-loaded or otherwise biased actuators 320, 330, which canmove components of the anastomosis actuation device 300 via depressionof one or more buttons. In other embodiments, threaded actuators thattwist relative to a housing of the housing 302 can be used. As will beevident from the discussion of additional embodiments below, actuationof the anastomosis actuation device 300 can also be achieved viahydraulic systems.

Additionally, the clamp tube handle 120, tract dilator 200, andanastomosis actuator 300 are discussed above as separate tools that canbe used in series to create an anastomosis of a conduit and a vessel. Insome embodiments, the tools can be provided to the clinician as separatetools, and the clinician can assemble and utilize the tools in a propersequence. In some embodiments the tools can be manufactured as a singletool capable of performing some or all of the functions discussed abovein creating an anastomosis.

With reference to FIG. 21, a proximal end of the conduit 318 can bepulled through skin tissue 52 to a position remote from the anastomosissite, or an exit site, at an outer surface of the skin. For example,known reverse tunneling procedures may be employed. In some embodiments,the conduit 318 can comprise a tissue ingrowth sleeve 321 positionednear the proximal end of the conduit 318 such that the sleeve 321 ispositioned in the subcutaneous region. In certain embodiments, tissue 52can grow into the tissue ingrowth sleeve 321, and can secure the conduit318 within the tissue 52. The tissue ingrowth sleeve 321 can aid inpreventing pathogens from migrating along an external surface of theconduit 318 toward the anastomosis site.

In some embodiments, a hub 322 can be attached to the proximal end ofthe conduit 318. The attachment can be accomplished via a barb fitting336 at the distal end of the hub 322 and a compression nut 323. The hub322 can have two ports 324, 325. A proximal port 324 can be used toinsert either one of a catheter and an obturator into the conduit 318,and the side port 325 can be used to infuse or withdraw fluids from theconduit 318. The hub 322 can also include a valve 326, such as a pinchvalve or a duck bill valve, to allow for selective occlusion of theconduit 318 when an obturator or catheter is not positioned therein. Theside port 325 can be directly associated with the hub 322 or can includea flexible extension tube 327 that is connected with the hub 322 at oneend and connected with an adapter 328 at the opposite end.

When not in use for hemodialysis or other procedures that can benefitfrom the vascular access provided by the conduit 318, an obturator 350can be used to maintain patency of the anastomosis opening and theconduit 318. The obturator 350 can provide selective fluid communicationbetween the vessel 51 and the conduit 318. The obturator 350 can includea connector 351 configured to couple with the proximal port 324 of theconduit hub 322. The obturator 350 can further include a shaft 352 and ahandle 353. The shaft 352 can be slidable within the connector 351,which can include sealing element 354, such as an o-ring, that isconfigured to contact the shaft 352 in a substantially fluid-tightengagement. The handle 353 can be attached to the proximal end of theshaft 352 and can engage a proximal portion of the conduit hub 322 witha locking mechanism 360 to prevent inadvertent removal of the obturator.Any suitable locking mechanism is contemplated, such as, for example,threading, a friction fit engagement, a snap, etc. The handle 353 caninclude a port 356 at its proximal end that provides fluid communicationto a bore of the shaft 352. The shaft 352 can be covered by a flexiblesleeve (not shown) to prevent contamination of the obturator 350 duringinsertion. For example, the flexible sleeve can be positioned over theshaft 352 between the handle 353 and the connector 351. As the handle353 is advanced toward the connector 351 to thereby advance the shaft352 into the conduit 318, the flexible sleeve can compresslongitudinally to allow the handle 353 to approach the connector 351.

The obturator 350 can include a tip 355 at the distal end of the shaftthat is configured to occlude the anastomosis opening. The tip 355 canplug the anastomosis opening to prevent blood from entering the conduit318. The tip 355 can extend slightly into the blood vessel 51 whenoccluding the anastomosis opening. The tip 355 can include a coatingthat is configured to prevent cell growth and thrombus formation overthe anastomosis opening. In some embodiments, the active agent of thecoating can include one or more of heparin, rapamycin, and other similaror equivalent agents.

The obturator shaft 352 can be substantially hollow and flexible. Incertain of such embodiments, the obturator 350 can include a stiffener(not shown) that can aid with the insertion of the obturator tip 355through the conduit 318 and into the anastomosis opening. The stiffenercan be positioned within the bore of the shaft 352, and in someembodiments, can be connected with the handle port 356. In someembodiments, the stiffener can be removed, and upon removal, can leavethe handle port 356 exposed.

In some embodiments, fluid can be flushed through the port 356, throughthe hollow shaft 352, through an opening 357 in the distal end of theshaft, through the conduit 318, and out of the hub side port 325. Insome embodiments, the shaft 352 can be coated with an antimicrobial andan antithrombogenic agent, such as EDTA, capable of being dissolved bythe fluid that is flushed through the connector. The dissolved agent cancreate a lock solution within the conduit 318 that is capable ofpreventing the formation of biofilm by bacteria. The agent can alsoprevent the formation of blood clots within the conduit 318. In furtheror other embodiments, an antimicrobial and/or antithrombogenic solutioncan be injected through the obturator shaft 352 or the hub side port 325and into the conduit lumen 352.

In use, the obturator connector 351 is secured to the proximal port 324of the conduit hub 322 with the shaft 352 extending proximally from theconnector 351. The obturator shaft 352 and the tip 355 are then advancedinto the conduit 318 and the tip 355 is seated in the anastomosisopening. The obturator stiffener (not shown) is then removed from theobturator 350. Fluid, such as a normal saline solution, heparin flushsolution, and/or an antimicrobial lock solution, can be injected intothe bore of the shaft 352 via the obturator handle port 356. A cap (notshown) can be connected to the handle port 356 to prevent leakage offluid therefrom.

The obturator 350 can be selectively inserted into and removed from theconduit hub 322 as desired. For example, in some embodiments, theobturator 350 is inserted after the anastomosis is originally formed andthereby occludes the anastomosis opening. When fluid communicationbetween the blood vessel 51 and the conduit 318 is desired, theobturator 350 can be removed, thereby opening the anastamosis opening.In some embodiments, upon removal of the obturator 350, a catheter (suchas may be used for hemodialysis) can then be inserted through theconduit hub 322, through the conduit 318, and into the blood vessel 51as described below. At the conclusion of a hemodialysis session, thecatheter can be removed from the vessel 51 and the conduit 318. Theobturator 350 then can again be inserted into the conduit 318 to occludethe anastomosis opening until a subsequent hemodialysis session.Additional apparatus and methods related to obturators configured tomaintain the patency of an anastomosis site can be found, for example,in U.S. Pat. No. 7,118,546, titled APPARATUS AND METHODS FORFACILITATING REPEATED VASCULAR ACCESS, which issued on Oct. 10, 2006,the entire contents of which are hereby incorporated by referenceherein.

Any suitable variety of catheter can be coupled with the conduit hub 322for any suitable procedure in which access to the blood vessel 51 isdesired. For example, in some embodiments, a dual-lumen cathetersuitable for use in hemodialysis may be employed. In some embodiments,only a distal tip of the catheter is inserted into the vessel 51, whichcan reduce the incidence of trauma to the intima layer of the vesselwall 53 as a catheter passes through the anastomosis site and into thevessel lumen 50. Hemodialysis can be performed by drawing blood into onelumen of the distal tip of the catheter and returning filtered bloodthrough the other lumen of the distal tip. Following a dialysis session,the catheter can be removed and replaced with the obturator 350, or itcan be stored or otherwise positioned in the conduit 318. In someembodiments, the catheter itself can act as the obturator when thecatheter is retracted into the conduit 318. For example, the distal endof the catheter can be configured to occlude the anastomosis opening ina manner such as that described with respect to the obturator tip 355.

FIGS. 22A and 22B illustrate an embodiment of a tract dilator 400, whichcan resemble the tract dilator 200 described above in certain respects.Accordingly, like features may be designate with like referencenumerals, with the leading hundreds numeral incremented to “4.” Anysuitable combination of the features described with respect to the tractdilator 200 can be employed with the tract dilator 400, and vice versa.As with the tract dilator 200, the tract dilator 400 can be configuredfor use with embodiments of the clamp assembly 100 and of theanastomosis actuation device 300.

In the illustrated embodiment, the tract dilator 400 can include anactuator 420, which can be connected with one or more legs 401 via oneor more arms 421. In some embodiments, the legs 401 and the arms 421 arepivotally connected to each other, whereas in other embodiments, theyare substantially fixed relative to each other. In the illustratedembodiment, each of the legs 401 and arms 421 is formed as an integralpiece, which may be capable of flexing. When in a closed or constrictedorientation, the legs 401 can define a small insertion tract 55.

The actuator 420 can include a lever 430, with which the arms 421 can bemechanically linked or otherwise operatively connected. The actuator 420can be positioned adjacent to a handle 432 to facilitate its actuationvia a squeezing action. Actuation of lever 430 can move the arms 421radially outward. In some embodiments, the ratchet lever 430 can beratcheted such that multiple squeeze cycles are used to effect thedesired amount of dilation of the tract 55. As shown in FIG. 22B, insome embodiments, the tract 55 is dilated such that a proximal endthereof is wider than a distal end thereof. A second grip handle 434 canbe provided for stabilization and ease of use in handling the actuator420.

In certain embodiments, the actuator 420 can be transitioned from theexpanded orientation shown in FIG. 22B back to the constrictedorientation shown in FIG. 22A by deactivating a lock, or via any othersuitable release mechanism, such that the arms 421 are released and thelegs 401 are moved radially inward due to the resilience of theseparated portions of the skin tissue 52.

In other embodiments, the actuator 420 may be coupled with the legs 401and arms 221 discussed above with respect to the tract dilator 200, andit may be used in place of the dilation actuator 220 (see FIGS. 9 and11). In such embodiments, the actuator 420 can be configured to causethe proximal ends of the arms 221 to move radially inward uponactuation, rather than radially outward as discussed with respect to thearms 421, such that the movement of the arms 221 and the legs 201 issubstantially the same as it is with the illustrated embodiment of thetract dilator 200.

FIGS. 23A-23H illustrate additional embodiments of a tract dilator 500,which can resemble the tract dilators 200, 400 described above incertain respects. Any suitable combination of the features describedwith respect to the tract dilators 200, 400 can be employed with thetract dilators 500, and vice versa. As with the tract dilators 200, 400,the tract dilators 500 can be configured for use with embodiments of theclamp assembly 100 and of the anastomosis actuation device 300.

As shown in FIGS. 23A-23C, a tract dilator 500 can include a pluralityof longitudinal ribbons 510 attached to a hub or ring 515 at theirproximal ends. In various embodiments, the tract dilator 500 includesthree or more, four or more, five or more, six or more, seven or more,or eight or more ribbons 510. The ribbons 510 can be positioned over theclamp assembly 100 prior to insertion of the clamp assembly 100 into theblood vessel 51, or can be positioned over the clamp assembly 100following clamping of the vessel wall 53. A sheath 520 can cover theribbons during insertion (see FIGS. 23A and 23B). The sheath 520 can besplit and separated, or peeled away, prior to expansion of the ribbons510, or the sheath 520 can be split automatically during the expansionprocess. The sheath 520 can facilitate insertion of the ribbons 510 intothe insertion tract 55, in some embodiments. As can be appreciated bycomparing FIGS. 23A and 23C, after being split, the sheath 520 can beremoved from the insertion tract 55.

As shown in FIG. 23D, in some embodiments, the ribbons 510 can havefeatures to prevent their backout from the insertion tract 55. Thefeatures can comprise one or more barbs 525 along a longitudinal face ora longitudinal edge of the ribbons 510. In some embodiments, thebackout-prevention features can define a dog-bone shape (not shown) orother suitable configuration at the distal end of the ribbons 510.

As shown in FIGS. 23E and 23F, the ribbons 510 can be connected viaflexible linkages 530. The linkages 530 can be initially substantiallylongitudinally oriented (see FIG. 23E). As the tract dilator 500 isradially expanded such that the distance between the ribbons 510increases, the linkages 530 can bend at points or positions at lateraledges of the ribbons 510 such that the orientation of the linkages 530can become more transverse relative to the longitudinal axis of thetract dilator 500 (see FIG. 23F). The interconnecting linkages 530 canhelp to prevent dilated tissue 52 from collapsing into the insertiontract 55. The interconnected ribbons 510 can be produced utilizing alaser cutting process or any other suitable technique. In otherembodiments, the tract dilator 500 can comprise a braided wire orstent-like device.

With reference again to FIG. 23C, in some embodiments the ribbons 510can be radially expanded via a plunger 530, which can be insertedthrough the hub 515. The plunger 530 can be a unitary device or it cancomprise a series of nested tubes having increasing diameters. Theplunger 530 can be a separate component or it can be integrated into theanastomosis actuation device 300. The plunger 530 can comprise a tip535, which can be relatively blunt in some embodiments or tapered inother embodiments, which may reduce dilatation forces. The plunger 530can be driven by hand (e.g., manually urged in a distal direction). Inother embodiments, the plunger 530 can be mechanically driven, such asby a piston utilizing hydraulic or pneumatic pressure.

In certain embodiments, as the plunger tip 535 moves toward the distalend of the ribbons 510, the ribbons 510 are forced radially outwardly soas to expand the insertion tract 55. Following tract dilation, theplunger 530 can be removed from the tract dilator 500. In someembodiments of the tract dilators 200, 400 discussed above, the legs201, 401, respectively, can be dilated via a plunger in a similarmanner, rather than via the actuators 220, 420.

As illustrated in FIG. 23G, in certain embodiments, the plunger tip 535can have grooves or notches 540 that engage the ribbons 510 of thedilator 500 as the plunger 530 is advanced distally. Engagement betweenthe notches 540 and the ribbons 241 can inhibit or prevent the plunger530 from rotating relative to the ribbons 510 during insertion.Additionally, in some embodiments, the plunger 530 defines an opening550 sized to receive the clamp tube 109. The plunger 530 can beconfigured to translate relative to (e.g., to slide over) the clamp tube109. As mentioned above, the anvil pull tube 106 can be received withinthe clamp tube 109, which is also shown in FIG. 23G.

With reference to FIG. 23H, in some embodiments a tract dilator 500 caninclude a balloon 560 that is configured to expand the ribbons 510,rather than the plunger 530. The balloon 560 is shown in an expandedstate. The balloon 560 can be positioned between the ribbons 510 and theclamp tube 109. The balloon 560 can comprise a material that iscompliant (e.g., stretchy or elastomeric), and thus capable ofstretching so as to expand, or can be non-compliant (e.g., substantiallyinextensible), and thus configured to unroll, unfold, or expanding insome other manner. Following vessel clamping, the balloon 560 can beexpanded using air or liquid. As the balloon 560 expands, the ribbons510 can be forced radially outward, thereby causing the insertion tract55 to be dilated. Following dilation, the balloon 560 can be removedfrom the tract dilator 500. In some embodiments of the tract dilators200, 400, the legs 201, 401, respectively, can be dilated via a balloonin a similar manner, rather than via the actuators 220, 420.

FIGS. 24A-24F illustrate embodiments of a tract dilator 600, which canresemble the tract dilators 200, 400, 500 described above in certainrespects. Any suitable combination of the features described withrespect to the tract dilators 200, 400, 500 can be employed with thetract dilators 600, and vice versa. As with the tract dilators 200, 400,500, the tract dilators 600 can be configured for use with embodimentsof the clamp assembly 100 and of the anastomosis actuation device 300.

In some embodiments the tract dilator 600 can comprise a foldable sleeve610 attached to a handle or hub device 615. In various embodiments, thesleeve 610 can define a diameter of from about 15 French to about 30French, no less than about 15 French, no less than about 20 French, noless than about 25 French, or no less than about 30 French when in anunfolded or expanded state. Other sizes are also contemplated. Forinsertion into the insertion tract 55, the sleeve 610 can be foldedtightly around the clamp assembly 100 such that an inner diameter of thesleeve 610 closely matches the outer diameter of the clamp tube 109.

As shown in FIGS. 24A-24C, to facilitate a smooth insertion of thesleeve into the insertion tract 55 and to maintain the sleeve 610 in afolded state, the sleeve 610 can be covered or encircled with asplittable or peel-away sheath 620. In some embodiments, the sheath 620can be manually split prior to expansion of the sleeve 610, and in otherembodiments, the sheath 620 can be split automatically during theexpansion of the sleeve 620.

With reference to FIGS. 24D and 24E, in some embodiments the dilatorsleeve 610 can be radially expanded via a plunger 630, which can beinserted into the sleeve 610 through the hub 615. The plunger 630 can bea unitary device or it can comprise a series of nested tubes havingincreasing diameters. The plunger 630 can be a separate component or canbe a part of the anastomosis actuation device 300. The plunger 630 cancomprise a tip 635, which can be relatively blunt in some embodiments ortapered in other embodiments so as to reduce dilatation forces. Theplunger 630 can be driven by hand (e.g., manually urged in a distaldirection). In other embodiments, the plunger 630 can be mechanicallydriven, such as by a piston utilizing hydraulic or pneumatic pressure.

In certain embodiments, as the plunger tip 635 moves toward the distalend of the sleeve 610, the sleeve 620 is forced radially outwardly so asto be unfolded and thereby dilate the insertion tract 55. In someembodiments, the sleeve 610 is fully expanded by the plunger 630, suchthat the insertion tract 55 can be dilated to any of the widthspreviously recited. Following tract dilation, the plunger 630 can beremoved from the tract dilator 600.

With reference to FIG. 24F, in some embodiments a tract dilator 600 caninclude a balloon 660 such as the balloon 560 instead of the plunger630. The balloon 660 can be positioned between the sleeve 610 and theclamp tube 109, and can be expanded using air or liquid. As the balloonexpands the sleeve 610 can be forced radially outward causing dilationof the insertion tract 55. Following dilation, the balloon 660 can beremoved from the tract dilator 660.

FIGS. 25-27 illustrate another embodiment of the clamp assembly 100,such as the clamp assembly shown FIGS. 2, 6, and 8. The proximal endsurface 105 of the anvil 104 is perpendicular to a longitudinal axis ofthe anvil 104. The proximal end surface 105 can be configured to engagethe cutter blade 310 during the cutting stage of an anastomosisprocedure, as described above. A proximal portion 190 of a peripheralsurface of the anvil 104 can be chamfered to facilitate passage of ananastomotic implant over the anvil 104 during the approximation stage ofan anastomosis procedure. A middle portion 191 of the peripheral surfaceof the anvil 104 can be parallel to a longitudinal axis of the anvil104. The middle portion 190 can provide an area to which the vessel wall53 retracts following cutting of the vessel wall 53 by the cutter tube309. A distal portion 192 of the peripheral surface of the anvil 104 canbe chamfered to provide a smooth transition from the introducer tip 101to the anvil 104. The smooth transition facilitates an easy insertion ofthe anvil 104 into a blood vessel 51 during the insertion procedure. Theanvil 104 can be made from a plastic material such as Delrin®, PVC,polyurethane or other materials that facilitate cutting of vessel walltissue when the cutter blade 310 and the anvil 104 engage. Embodimentsof the anvil 104 can be manufactured using known manufacturing methodssuch as injection molding, machining, or casting.

With continued reference to FIGS. 25-27, a tissue capturing tubularstructure 133 is shown nested in the anvil 104. The tubular structure133 can have at least one spike like projection or tooth 115 extendingproximally beyond the proximal end face 105 of the anvil 104. In someembodiments, the number of teeth can be from 12 to 18. The teeth 115 canbe barbed shape with a single barb or double barbs. In some embodiments,the tissue capture tube 133 can be made from stainless steel using alaser to cut the tube from a tube.

As shown in FIG. 25, the distal end of the anvil pull tube 106 issecurely fastened not only to the anvil 104, but also the introducer tip101. As shown in FIGS. 26 and 27, when the clamp assembly 100 is in theclosed orientation, a distal surface of the clamp foot 110 can contactthe proximal tips or spike-like projections of the teeth 115. The clampfoot 110 can be devoid of notches (see FIG. 26), but blood can still bepermitted to flow into the opening 112 through spaces between adjacentteeth 115.

In the illustrated embodiment, the teeth 115 are fixedly secured to theanvil 104, rather than to the clamp foot body 137. Accordingly, when theclamp assembly 100 is moved to the open orientation shown in FIG. 33,the clamp foot 110 can be spaced from the teeth 115 by a relativelylarger amount. In some cases, this can permit the vessel wall 53 (see,e.g., FIG. 6) to more easily resiliently close around the clamp footbody 137 within the region of the gap 132. A diameter of the clamp foot110 can be approximately equal to the diameter of the tissue capturetube 133 such that the clamp foot 110 rests on the teeth 115 when theclamp is in the clamp closed position. When the clamp assembly 100 ismoved to the closed orientation, the clamp foot 110 can compress thevessel wall 53 onto the portions of the teeth 115 that extend above aproximal surface 105 of the anvil 104 to provide a secure capture of thevessel wall 53.

FIGS. 28 and 29 illustrate an embodiment of a vascular accessimplantation device 700, which can be configured for implanting avascular access port within a patient. The implantation device 700 canbe configured to manage tissue during an anastomosis procedure andlikewise to form the anastomosis itself. The implantation device 700 isdescribed hereafter with respect to the implantation of a subcutaneousaccess port. However, other embodiments can be suitable for implantationof percutaneous devices, such as the conduit 318 and conduit adapter 304described above. Accordingly, the specific examples provided hereaftershould not be construed to limit the disclosure.

The implantation device 700 can include a clamp actuation device 720,which can resemble the clamp actuation device 120 discussed above inmany respects, and thus like features are identified with like referencenumerals with a leading hundreds numeral incremented to the value “7.”The implantation device 700 can further include a tract dilator 800,which can resemble the tract dilator 200 discussed above in manyrespects, and thus like features are identified with like referencenumerals with a leading hundreds numeral incremented to the value “8.”The implantation device 700 can further include an approximationassembly or anastomosis actuation device 900, which can resemble theanastomosis actuation device 300 discussed above in many respects, andthus like features are identified with like reference numerals with aleading hundreds numeral incremented to the value “9.” Therefore, theforegoing discussion regarding similarly numbered features is equallyapplicable hereafter and, accordingly, might not be repeated. Forexample, method steps or procedural stages for preparing an anastomosissite and performing an anastomosis described above, although notexplicitly recited hereafter, may be performed via the implantationdevice 700. It is further noted that any suitable combination of thefeatures described with respect to one or more of the clamp actuationdevice 120, the tract dilator 200, and the anastomosis actuation device300 can be employed with the clamp actuation device 720, the tractdilator 800, and the anastomosis actuation device 900, respectively. Theconverse is also true.

The implantation device 700 can further include the clamp assembly 100.Numerous embodiments of the clamp assembly 100 are described above, andany suitable embodiment may be used with the implantation device 700.Likewise, any variations of the clamp assembly 100 that may be notedhereafter can be used in the embodiments described above. Accordingly,the foregoing discussion regarding the clamp assembly 100 is equallyapplicable hereafter and might not be repeated.

Embodiments of the implantation device 700 can differ from certain ofthe previously discussed embodiments in other respects. For example, inthe illustrated embodiment, the clamp actuation device 720, the tractdilator 800, and the anastomosis actuation device 900 are assembled as asingle unit so as to be able to function substantially withoutdisassembly of the implantation device 700. Stated otherwise, each ofthe clamp actuation device 720 and the anastomosis actuation device 900can be simultaneously physically connected to the tract dilator 800,whether the physical connection is direct or indirect.

Moreover, in the illustrated embodiment, the functionalities of each ofthe dilation actuator 220, the cutter actuator 320, and theapproximation actuator 330 discussed above can be achieved viapressurized fluids. In other embodiments of the implantation device 700,pressurized fluids may be used for only one or only two of the foregoingactuator functionalities, or may be used for other (and/or additional)functionalities. As discussed in greater detail below, the implantationdevice 700 can include a dilation pressure port 750, a cutter pressureport 760, and/or an approximation pressure port 770 via which theactuator functionalities may be controlled. Each of the ports 750, 760,770 can include a connector 752, 762, 772, respectively, which can beconfigured to couple with a pressurizing device, and each connector 752,762, 772 can be in fluid communication with a separate fluid line ortube 754, 764, 774, respectively, that can deliver fluid to a specificregion of the implantation device 700. The distal ends of the tubes 754,764, 774 are not shown in FIGS. 28 and 29, but they are discussedhereafter.

In the illustrated embodiment, one or more of the connectors 752, 762,772 comprise one or more of a luer connector that is configured tocouple with an inflation syringe and/or a stopcock that is configured toselectively release or maintain a pressure provided to the ports 750,760, 770. Suitable varieties of inflation syringes that can be used topressurize portions of the implantation device 700 are known in the art,including inflation syringes that are generally used in angioplastyprocedures.

With continued reference to FIGS. 28 and 29, the implantation device 700can include a primary housing 740. In the illustrated embodiment, theprimary housing 740 is connected to and/or interacts with each of theclamp actuation device 720, the tract dilator 800, and the anastomosisactuation device 900. Specifically, the clamp actuation device 720 isfixedly attached to a proximal end of the primary housing 740, theanastomosis actuation device 900 is received within and is selectivelymovable relative to the primary housing 740, and the tract dilator isfixedly attached to a distal end of the primary housing 740. The fixedconnections between the clamp actuation device 720 and the primaryhousing 740 and between the tract dilator 800 and the primary housing740 can be of any suitable variety, including, for example, hardwareconnections (e.g., nuts, bolts, screws, pins, etc.), adhesive bonds,and/or ultrasonic welds. The connection and the interaction between theanastomosis actuation device 900 and the primary housing 740 arediscussed further below.

With reference to FIGS. 30 and 31, in certain embodiments, the primaryhousing 740 can be sized, shaped, or otherwise configured to functionsubstantially as a handle. For example, in the illustrated embodiment,the primary housing 740 is shaped substantially as a hollow cylinderopen at both ends, and can be generally circular in cross-section. Othercross-sectional configurations are also possible, including generallyelliptical, generally rectangular, etc. A longitudinal contour of anexterior surface 741 of the primary housing 740 can be generally shapedas an hour-glass or dumbbell, such that the proximal and distal endsdefine larger outer diameters than does a central region.

The proximal end of the primary housing 740 can define a recess 742configured to receive a distal portion of the clamp actuation device720. Similarly, the distal end of the primary housing 740 can define arecess 743 configured to receive a proximal portion of the tract dilator800. In the illustrated embodiment, the distal recess 743 is stepped,and is somewhat larger than the proximal recess 742.

An insertion channel 744 can extend between the proximal and distalrecesses 742, 743. As further discussed below, the insertion channel 744can be configured to permit the anastomosis actuation device 900, or aproximal portion thereof, to slide or otherwise translate therein. Theinsertion channel 744 can be defined by an interior surface 745 of theprimary housing 740, which, in the illustrated embodiment, substantiallydefines a cylinder.

The primary housing 740 can define a slot 746, which can extend almostthe full length or a substantial portion of the insertion channel 744.In the illustrated embodiment, the slot 746 is substantially parallel toa longitudinal axis of the primary housing 740. The slot 746 can fullyextend through a sidewall of the primary housing 740 (e.g., through boththe interior surface 745 and the exterior surface 741). One or morelocking recesses 747 can be formed at or near a distal end of the slot746. In the illustrated embodiment, a single locking recess 747 extendstransversely about a periphery (e.g., about the circumference) of theinner surface 745 that defines the insertion channel 744. As furtherdiscussed below, the locking recess 747 can be used to secure theanastomosis actuation device 900 in an extended position.

In some embodiments, the primary housing 740 can define a viewing window748, which can aid in detecting a position of the tract dilator 800, asfurther discussed below. The viewing window 748 can extend through awall of the housing near a proximal end of the distal recess 743. Theprimary housing 740 can be formed from any suitable material, such as,for example, metal or plastic material, utilizing any suitablemanufacturing technique, such as, for example, machining or injectionmolding.

With reference to FIG. 32, the clamp actuation device 720 can include ahousing 735. In some embodiments, the housing 735 comprises two portionshaving a clam shell configuration. The portions of the housing 735 canbe secured together in any suitable manner, such as with fasteners(e.g., bolts, nuts, screws, etc.), a snap fit, ultrasonic welding, etc.A first of the two portions is shown in FIG. 32, and the second can beseen in FIGS. 28 and 29. As with other housings described above andhereafter, the housing 735 can comprise any suitable material, such as amedical grade plastic or metal, and can be formed via any suitablemanufacturing method, such as by machining or injection molding.

The housing 735 can define a recess 781 to accommodate movement of aclamp actuator 721, which is discussed further below. Additionally, insome embodiments, the housing 735 can define one or more channels 782through which one or more of the tubes 754, 764, 774 can pass. Forclarity, only tube 764 is shown in FIG. 32. The clamp tube 109 of theclamp assembly 100 can be fixedly attached to the housing 735.

As with the clamp actuation device 120, the clamp actuation device 720can allow for withdrawal of blood and/or air from the vicinity of ananastomosis site via the clamp assembly 100 in order to determine aposition of the distal portions of the clamp assembly 100. The clampactuation device 720 can include a bodily fluid marker chamber 729 thatis in fluid communication with a tube 74 and with the channel 113between the clamp tube 109 and the anvil pull tube 106 (see FIG. 32).The clamp actuation device 120 can further include sealing devices 728(e.g., o-rings) at either side of the bodily fluid marker chamber 729 toprevent leakage of blood or air. In the illustrated embodiment, thebodily fluid marker chamber 729 includes a channel that is positioned atthe interface of the two joined portions of the housing 735. In otherembodiments, the channel comprises a bore through a single portion ofthe housing 735, which can aid in preventing leakage of blood or airfrom the channel through the interface.

With reference to FIGS. 32 and 33, the clamp actuator 721 can include anouter arm 722 and an inner arm 723 that are pivotally coupled to eachother via a linking arm 784. The inner arm 723 can be substantiallyL-shaped, with a first section extending in a direction substantiallyparallel to a longitudinal axis of the clamp actuator 721 and a secondsection extending substantially transverse thereto. In the illustratedembodiment, the transverse section of the inner arm 723 is fixedlyattached to a proximal end of the anvil pull tube 106. The transversesection of the inner arm 723 can also contact a biasing member 711,which can provide a proximally directed longitudinal biasing force tothe inner arm 723. The biasing force thus can bias the clamp actuator721 to the closed orientation shown in FIG. 32. The biasing member 711can comprise any suitable biasing device, such as a compression springor one or more Bellville washers.

The clamp actuator 721 can be moved between closed orientation (FIG. 32)and the open orientation (FIG. 33), which can move the clamp assembly100 between the closed orientation and the open orientation (asdiscussed above), respectively. In the illustrated embodiment, the clampactuator 721 can be moved to the open state by rotating the outer arm722 toward a distal end of the clamp actuation device 720. The outer arm722 can be substantially perpendicular to a longitudinal axis of theactuation device 720 when in the open state. The clamp actuator 721 canbe in the closed state when the outer arm 722 is rotated toward aproximal end of the clamp actuation device 720 so as to be substantiallyparallel to the longitudinal axis of the clamp actuation device 720.

In the illustrated embodiment, the outer arm 722 includes a pin 785 andthe linking arm 784 includes a slot 786. As shown in FIG. 33, when theouter arm 722 is moved to the open orientation, the pin 785 can bereceived in the slot 786. In some embodiments, the pin-and-slotarrangement can provide for a compact actuator 721. In other or furtherembodiments, the slot 786 can interact with the pin 785 to maintain theactuator 721 in the open orientation. For example, in some embodiments,the slot 786 can frictionally engage the pin 785, or snap over the pin785, so as to overcome the biasing force of the biasing element 711. Auser than can selectively maintain the actuator 721 in the openorientation, which in some cases can facilitate manipulation of clampassembly 100 to capture the vessel wall 53 (see FIG. 5). Other methodsfor selectively locking or maintaining the clamp actuator 721 in theopen orientation are also possible.

With reference to FIG. 32, the clamp actuation device 720 can be coupledwith a base 790 and can function as a cutter piston 791. In theillustrated embodiment, the clamp actuation device 720 is coupled with aplunger 793 that extends distally. The plunger 793 can be substantiallycylindrical. The base 790 can include an inner wall 794 and an outerwall 795. In the illustrated embodiment, the inner and outer walls 794,795 are formed of separate pieces, but they can be formed of a unitarypiece in other embodiments. The inner and outer walls 794, 795 cooperateto define a pressure channel 796. In the illustrated embodiment, thepressure channel 796 is substantially cylindrical, and is closed at itsdistal end by a distal wall of the base 790.

The tube 764 can be coupled with the pressure channel 796 so as toprovide fluid communication between the connector 764 and the pressurechannel 796. For example, in the illustrated embodiment, the tube 764can extend through one of the channels 782 through the housing 735, anda distal end of the tube 764 can extend through the inner wall 794 ofthe base so as to provide fluid communication between the connector 762and the pressure channel 796. In other embodiments, the tube 794 canextend through the outer wall 795, and in further embodiments, the tube794 can merely be coupled with the base 790 in a fluid-tight engagementwithout extending through the inner or outer walls 794, 795.

A proximal end of the pressure channel 796 can be sealed by the plunger793. For example, in the illustrated embodiment, the cylindrical plunger793 fits snugly within the cylindrical pressure channel 796. Sealingmembers 797, such as o-rings, can be positioned between the plunger 793and each of the inner and outer walls 794, 795 to seal the upper end ofthe pressure channel 796. In the illustrated embodiment, an upper orproximal end of the plunger 793 has a reduced diameter, and a distalsurface of the reduced-diameter portion interferes with an upper end ofthe inner wall 794 to prevent the plunger 793 from completely fillingthe pressure channel 796 and/or from blocking a fluid path at the distalend of the tube 764.

The cutter piston 791 and the base 790 can cooperate to effect cuttingof a vessel wall 53, and thus together can be considered as a cutteractuator 920, such as the cutter actuator 320. For example, aspreviously discussed, the anvil pull tube 106 is fixedly attached to theinner arm 723 of the clamp actuation device 720 such that proximalmovement of the cutter piston 791 effects proximal movement of the anvilpull tube 106. The implantation device 700 can include a cutter tube 909(see FIG. 36), and sufficient proximal movement of the anvil pull tube106 can bring the anvil 104 (see FIGS. 28 and 29) into contact with ablade 910 of the cutter tube 909 in a manner similar to that describeabove with respect to the anastomosis actuation device 300.

The cutter piston 791 can be caused to move proximally relative to thebase 790 by introduction of pressurized fluid into the pressure channel796. In the illustrated embodiment, a inflation syringe (not shown) canbe coupled with the connector 762 and pressurized fluid can be deliveredto the pressure channel 796 via the tube 764. The pressurized fluid canapply pressure to a distal end of the plunger 793, thereby causing thecutter piston 791 to move proximally. In various embodiments, thepressure of the fluid within the pressure channel 796 at which cuttingof the vessel wall 53 takes place and/or at which the blade 910 embedswithin the anvil 104 is from about 2 atmospheres to about 6 atmospheres,no less than about 2 atmospheres, no less than about 3 atmospheres, noless than about 4 atmospheres, no less than about 5 atmospheres, or noless than about 6 atmospheres.

In some embodiments, once the cutting has taken place, the elevatedpressure within the pressure channel 796 can be maintained. For example,a stopcock (not shown) can be adjusted to seal the pressurized fluidwithin the pressure channel 796, or the inflation syringe can remaincoupled with the connector 762. Maintaining the pressure within thepressure channel 796 can have a similar effect to locking the cutteractuator 320 in the actuated orientation. As previously discussed, insome embodiments, it can be desirable to maintain the anvil 104 and thecutter tube 309 (or, in the present case, the cutter tube 909) incontact throughout final stages of an anastomosis procedure, such that acut portion 334 of the vessel wall 53 is maintained between the clampassembly 100 and the cutter tube 309 (or 909).

FIGS. 35 and 36 illustrate an embodiment of the anastomosis actuationdevice 900. Much of the anastomosis actuation device 900 can be the sameas or similar to the anastomosis actuation device 300 discussed above.For example, the anastomosis actuation device 900 can include a lowerhousing 902, an adapter tube 903 fixedly attached to the lower housing902 at a proximal end thereof and connected to a retaining adapter 904at a distal end thereof, an anastomosis implant 918 temporarily attachedto the retaining adapter 904, an actuator tube 911 inside the adaptertube 903, and a cutter tube 909 inside the actuator tube 911.

The anastomosis actuation device 900 can be telescopically positionedover the clamp tube 109 and within the primary housing 740, and can beslidable or translatable from an initial, retracted position to anactuated, extended position. In certain embodiments, the lower housing902 can include an extension actuator 970, such as a pin or a knob, thatcan extend radially outward from the lower housing 902. As partiallyshown in FIG. 28, the extension actuator 970 can extend through thelongitudinal slot 746 of the primary housing 740. The extension actuator970 can function as a handle or grip to facilitate movement of theanastomosis actuation device 900 from the retracted position to theextended position. In some embodiments, a protrusion 972 can extend fromthe implantation device 700 at a position distal of the extensionactuator 970, such as from a side of the tract dilator 800. Theprotrusion 972 can aid in the deployment of the anastomosis actuationdevice 900 from the retracted position to the extended position, as bothprotrusion 972 and the extension actuator 970 can be held simultaneouslyand squeezed toward each other.

When moved to the extended position, the anastomosis actuation device900 can lock into place to prevent inadvertent retraction of theanastomosis actuation device 900. The locking can be achieved by one ormore spring pins that extend radially outwardly from the lower housing902 being released outwardly into the one or more locking recesses 747.The spring pin can be compressed by the primary housing 740 when theanastomosis actuation device 900 is in its initial retracted position,as well as during translation of the anastomosis actuation device 900toward the extended position, and can be released to its biased stateupon reaching the one or more locking recesses 747.

The retaining adapter 904 can be similar to the retaining adapter 304.For example, the retaining adapter 904 can include one or more retentionchannels 914 that are configured to interface with one or more retentionlegs 907 of an anastomosis clip 905. However, in some embodiments, theretaining adapter 904 can exhibit certain differences. For example, inthe illustrated embodiment, the retaining adapter 904 is shaped toaccommodate the positioning of an anastomosis implant 918 therein. Theillustrated embodiment of the retaining adapter 904 is radiallynonsymmetrical to accommodate an anastomosis implant 918 that has anaccess port 980 at one side thereof (see also FIG. 40).

Although the anastomosis implant 918 can be different from the conduit318, as further discussed below, the anastomosis implant 918 can includean anastomosis adapter 913 (FIG. 40) that is similar to the conduitadapter 313. The anastomosis implant 918 can be attached to theanastomosis adapter 913 or can be integrally formed therewith such thatthe anastomosis adapter 913 and the anastomosis implant 918 form aunitary structure. The anastomosis adapter 913 can include connectionchannels configured to interface with connection legs of the clip 905 inthe same manner that the connection channels 313 interface with theconnection legs 308 of the clip 305.

The anastomosis procedures described above with respect to the conduit318 and the conduit adapter 313 can be substantially the same as thoseby which the anastomosis implant 918 is connected to a vessel. However,in the illustrated embodiment, an approximation actuator 930 takes theplace of the approximation actuator 330. With reference to FIG. 36, theapproximation actuator 930 can comprise an upper housing 980 thatdefines an annular pressure channel 982 and a plunger 984. The upperhousing 980 can be comprised of one or multiple pieces. The plunger 984can be positioned in the pressure channel 982, and may include aseparate sealing member 986, such as an o-ring, at each of an inner andan outer interface with the upper housing 980. The plunger 984 thus canhave a fluid-tight seal with the upper housing 980 so as to close adistal end of the pressure channel 982. The cutter tube 909 may befixedly attached to the upper housing 980.

Referring to FIGS. 37-39, an embodiment of a tract dilation assembly (ortract dilator) 800 is shown. The tract dilation assembly can include adilator handle, a dilator pressure port and one or more dilator legs.The tract dilation assembly 800 proximal end can engage the tool housing740 distal end. The tract dilation assembly 800 can be telescopicallypositioned over the clamp tube 109 with the clamp tube 109 extendingbeyond the proximal and distal ends of the tract dilation assembly 800.The distal portion of the approximation assembly 900 can extend into thetract dilation assembly 800 when the approximation assembly 900 is inits initial position. When the approximation assembly 900 is in itsextended position, the approximation assembly 900 distal end can alignwith the tract dilation assembly 800 distal end.

The tract dilation handle can be generally cylindrical in shape with abore passing through the handle. The tract dilation pressure port canengage the proximal end of the dilator handle. The pressure port caninclude a port body and a plunger. The port body can have an inner walland an outer wall with an annular space between them. The annular spacecan be closed at its distal end and open at its proximal end. Theplunger can be telescopically positioned at least partially within theannular space. O-rings near the distal end of the plunger facilitate aliquid seal of the annular space. A fluid channel through the port bodyinner wall or outer wall can provide fluid communication from outsidethe tract dilator to the annular space to facilitate pressurization ofthe annular space. The plunger proximal portion can extend proximallybeyond the annular space. The proximal portion can have an inner surfacethat is tapered. The tapered surface can be a cam surface forinteraction of the proximal end of the dilation leg.

The tract dilation assembly 800 can include three dilation legs. Thelegs can be pivotally secured to the interior of the dilation handle andextend distally beyond the dilation handle. The leg can be madeintegrally as a single component or can be made of two or morecomponents, a dilation portion and a lever portion. The two componentscan be secured together using methods such as welding, screws, pins orother known methods. The leg can be made from a rigid material such asstainless steel. The leg dilation portion can be configured to closelysurround the clamp tube. The leg dilation portion can be radiussedexteriorly and interiorly such that the leg conforms to the shape of theclamp tube. Each leg can cover approximately 120° of the clamp tube 109circumference to form a nearly solid surface. The leg distal end canabut the clamp foot 110 flange. The diameter of the three legs at thedistal end can be approximately equal to the diameter of the clamp foot110 flange to facilitate a smooth insertion of the dilation legs throughthe tissue and vessel wall. The leg outside surface can be tapered justproximal to the leg distal end. The increased thickness of the leg atits mid and proximal portions can increase stiffness to prevent flexingof the leg during tract dilation.

The dilation leg lever portion can be configured to accommodate theapproximation assembly adapter when the approximation assembly is in theretracted position. The leg lever portion proximal end can be configuredto engage the plunger cam surface. A pivot pin near the lever portionproximal end can secure the leg to the tract dilator handle and functionas a pivot point for the leg.

In use, the annular space of the tract dilator pressure port can bepressurized with a fluid through the fluid channel. The plunger can beforced by the pressurized fluid to move in a proximal direction. As theplunger moves proximally, the leg lever portion proximal end can engagethe plunger cam surface. The leg lever proximal end can pivot inwardaround the pin and the leg dilation portion can move radially outward todilate the tissue of the insertion tract. The dilated tract can be atriangular shape sized to accommodate the passage of the approximationadapter when the approximation assembly is moved to an extendedposition.

As previously mentioned, methods for using the implantation device 700will be evident from the disclosure herein. Additional examples of suchmethods are now provided. In some instances, a method of anastomosingthe anastomosis implant 918 to a vessel wall 53 can include passing theimplantation device 700 over a guidewire 103 which has been positionedin the lumen 50 of a blood vessel 51 using known techniques. Theguidewire 103 can pass through the tip 101, the anvil 104, into theanvil pull tube 106 and exit the proximal end of the anvil pull tube106. The tip 101, the anvil 104 and the clamp foot 110 can be insertedthrough the subcutaneous tissue and through the vessel wall 53 into thelumen 50 of the blood vessel 51. The distal portion of the dilator legscan also be inserted into the vessel lumen 50. When the clamp foot is inthe vessel lumen, blood can be drawn through the port 112 in the clampfoot 110 into the annular space between the anvil pull tube 106 and theclamp tube 109. The blood can flow into the bodily fluid marker channelin the clamp handle and exit into the lumen of the flexible tubeattached to the external orifice of the channel. The blood can bevisualized by the clinician and can confirm insertion of the anvil 104and clamp foot 110 into the lumen 50 of the vessel 51.

The clamp lever can be moved from the clamp closed position to the clampopen position. Movement of the clamp lever can move the anvil pull tube106 distally resulting in a separation of the anvil 104 and clamp foot110 and the formation of a gap between the anvil 104 and clamp foot 110.Separation of the anvil 104 and clamp foot 110 can expose theprojections 115 of the tissue capture tube 133. The guidewire 103 can beremoved from the vessel 51 and the anastomosis tool 700. The anastomosistool 700 can be moved proximally allowing the vessel wall 53 to slideover the clamp foot 110 flange and into the gap. As the vessel wall 53passes into the gap, the dilated hole in the vessel wall 53 reduces indiameter due to the elasticity of the vessel wall tissue. The vesselwall 53 is caught by the projections 115 of the tissue capture tube 133.The clinician can sense a resistance to further proximal movement of theanastomosis tool 700 due to the capture of the vessel wall 53 by thetissue capture tube 133. Blood can stop flowing into the bodily fluidmarker tube due to capture of the vessel wall 53 distal to the bodilyfluid marker port 112 in the clamp foot 110. The stoppage of blood flowthrough the bodily fluid marker can confirm vessel wall capture in thegap between the anvil 104 and clamp foot 110 flange. The clamp lever canbe moved to the clamp closed position. This can result in proximalmovement of the anvil 104 and closing of the gap between the anvil 104and clamp foot 110. The anvil pull tube 106 can be biased proximally bythe springs in the clamp handle resulting in compression of the vesselwall tissue onto the projections 115 of the tissue capture tube 133.

The insertion tract surrounding the implant tool 700 can be dilated tofacilitate positioning of the implant 918 adjacent to the vessel wall53. The tract dilation pressure port can be pressurized. When the portis pressurized, the plunger can move proximally. The cam at the proximalend of the plunger can engage the dilation leg proximal end causing theleg proximal portions to pivot radially inward around the pivot pin. Thedilator leg distal portion can pivot radially outward away from theclamp tube 109. As the legs move outward, tissue surrounding the legscan be moved away from the anastomosis tool 700. A tract dilator havingthree legs can form an expanded triangular shaped insertion tract 55around the clamp tube 109 of the tool 700. A tract dilator having fourlegs can form a generally square or rectangular shaped insertion tract55. The expanded tract 55 can be formed from the epidermis to the outersurface of the blood vessel wall 53. In some embodiments, all layers ofskin, subcutaneous tissue and facia layers to the outer surface of theblood vessel 51 can be cleared from the insertion tract 55 surroundingthe anastomosis tool 700.

The approximation assembly 900 can be moved distally from its retractedposition to its extended position. The adapter 904 can pass between thedilator legs into the expanded insertion tract 55. The adapter 904distal end and the implant 918 assembly can be positioned adjacent tothe vessel wall 53. The approximation assembly 900 handle can be lockedinto the extended position relative to the tool housing 740.

An anastomosis opening can be cut in the vessel wall 53 by pressurizingthe cutter pressure port with fluid causing the cutter plunger 793 andinner arm 723 of the clamp actuation device 720 to move proximally.Proximal movement of the inner arm 723 of the clamp actuation device 720can result in proximal movement of the anvil pull tube 106. The anvilpull tube 106 can pull the anvil 104 and the captured vessel wall 53into the implant 918. Continued movement of the cutter plunger 793 canpull the anvil 104 and the captured vessel wall 53 against the cuttingblade 910 of the cutter tube 909. The blade 910 can cut through thevessel wall tissue and partially embed into the anvil 104 proximal end.The cut vessel wall 53 partially retracts distally along the anvil 104.The opening of the implant 918 can be sized to facilitate compression ofthe vessel wall 53 against the anvil 104. The compression of the vesselwall 104 prevents the vessel wall 104 from full retraction out of theimplant 918.

The anastomosis of the implant 918 to the vessel wall 53 can becompleted by approximating the implant 918 and clip 905. Theapproximation port can be pressurized with fluid. When pressurized, theapproximation port plunger 984 can move distally. As the plunger 984moves distally, the approximation tube 911 can engage the implant 918and move the implant 918 distally. With continued movement, the implant918 can engage the partially retracted vessel wall 53 and evert thevessel wall 53 over the clip 905. The everted vessel wall 53 can becompressed between the implant 918 and the clip 905.

Following approximation of the clip 905 and the implant 918, additionalpressurization of the approximation pressure port increases the forceapplied to the implant 918 by the approximation tube 911. The increasedforce can result in ejection of the implant 918 from the implant tool700. The implant tool 700 can then be removed from the insertion site.

The implant tool 700 can be provided to a clinician pre-assembled in asterile package (not shown). Also, provided in the package can beancillary medical devices to facilitate utilization of the implant tool700. The ancillary medical devices can include a micro-puncture set, aguidewire, dilators, syringes, needles and a scalpel. The implant tool700 can be a onetime use medical device. In other embodiments, theimplant tool 700 can be configured to be used for multiple vascularaccess port implantations.

What is claimed is:
 1. A system comprising: an introducer tip configuredto be inserted into a vessel of a patient; an anvil configured to beinserted into the vessel of a patient, wherein the anvil is proximal tothe introducer tip to permit the anvil to be inserted into the vesselafter the introducer tip has been inserted into the vessel, wherein theanvil comprises a proximal surface; a pull tube fixed to the anvil; aclamp foot; a clamp tube fixed to the clamp foot, wherein the pull tubeand the clamp tube are movable relative to each other to selectivelymove the anvil and the clamp foot between a closed state in which theanvil and the clamp foot are in close proximity to each other and anopen state in which the anvil and the clamp foot are spaced further fromeach other than when they are in the closed state, and wherein the anviland the clamp foot are configured to hold a wall of the vessel betweenthem when in the closed state; and a cutter tube that comprises a cutterat a distal end thereof, wherein the cutter tube is movable relative tothe pull tube and the clamp tube and is configured to pass over theclamp foot to bring the cutter into contact with the proximal surface ofthe anvil to cut the wall of the vessel when the anvil and the clampfoot are holding the wall of the vessel when in the closed state.